IJPAR | International Journal of Pharmacy and Analytical Research

International Journal of Pharmacy and Analytical Research

ISSN: 2320_2831

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  1. HPLC method development and validation for simultaneous determination of lamivudine and tenofovir in tablet dosageDownload Article

    Vishnumanikandan N, Shine Sudev, Najuma Salim,, Ajmal Shareef K, Sapna Shrikumar
    • Article Type: Research Article
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    • Pages (193-201)
    • No of Download = 628

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    A simple, reverse-phase high performance liquid chromatographic method has been developed and validated for the simultaneous estimation of Lamivudine and Tenofovir disoproxil fumarate in pure and tablet dosage form. The chromatographic Separation was carried out using on Hypersil BDS C18 column (250 x4.6mm id, 5m particle size) in isocratic mode with flow rate of 1mLmin-1 and the detection was carried out by photo diode array detector at 260nm. The mobile phase consists of 0.01N Sodium Dihydrogen Ortho Phosphate Buffer (pH 4.5±0.5) and acetonitrile in the ratio of 50:50 (v/v). The retention time for Lamivudine and Tenofovir was found to be 2.18mins and 3.64mins respectively. The linearity was obtained in the concentration range of 75- 450µgmL-1 for both the Lamivudine and Tenofovir Disoproxil Fumarate. The LOD was found 0.92µgmL-1 and 2.37µgmL-1 for Lamivudine and Tenofovir respectively, whereas LOQ was found to be 2.79µgmL-1 for Lamivudine and 7.17µgmL-1 for Tenofovir. The percentage recovery was found to be 99.84 – 100.54 for Lamivudine and 99.72 – 100.82 for Tenofovir respectively. The method was statistically validated as per ICH guidelines and %RSD was found to be less than 2 indicating high degree of accuracy and precision of the proposed HPLC method.

  2. A novel liquid oral formulation for 1- Octacosanol an anticancer drug and its stability studyDownload Article

    Shaji KP, Umesha S and Bharathi P.Salimath
    • Article Type: Research Article
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    • Pages (202-209)
    • No of Download = 1223

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    1-Octacosanol is a long chain fatty acid alcohol and a liphophilic waxy compound and hence by nature it is insoluble in water. Therefore, the respective drug active encounters a challenge of active absorption in the clinical settings. Thus, a necessity for the development of water soluble, a bio absorbable and a palatable formulation for 1- Octacosanol was addressed in this study. Apart from this, a secondary objective of presenting this drug product to pediatric and geriatric patients in a palatable manner, in order to increase their compliance. Various galenical feasibility studies were conducted to identify the specific ingredients and its respective proportion to bring out the desired emulsion. The resultant formulation facilitates the increased bioavailability; herewith we disclose a novel liquid oral emulsion formulation. It is a liquid oral emulsion dosage form of oil in water type, containing adjuvants like Corn oil, Tween -80, Span-60, Sucralose, Flavour (raspberry), Water (DM), Simethicone, Methyl paraban, Propyl paraban etc. The final product exhibit a milky white emulsion, was further tested for its physical stability and its palatability through numerous experiments.

  3. Crystal investigation and characterization of the pseudopolymorphic forms of gemifloxacin mesylateDownload Article

    Ganesan V and Ethiraj T
    • Article Type: Research Article
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    • Pages (210-218)
    • No of Download = 926

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    Main objective of this present study was to prepare and investigate the different pseudo polymorphic forms of gemifloxacin using Powder X-Ray Diffraction analysis (PXRD), Scanning Electron Microscopy (SEM), Differential Scanning Calorimetry (DSC), Fourier Transform Infrared Spectrometry (FTIR) and dissolution studies. For this purpose, crystals of gemifloxacin (G-1 to G-4) were obtained by solvent evaporation method using various solvents like isopropanol, chloroform, dichloromethane and benzene and characterized. Pseudo polymorph obtained from isopropanol (G-I) showed highest solubility and percentage drug release than others. The existence of different polymorphic forms of gemifloxacin has been proved by appearance and disappearance of peaks on the PXRD graph and melting points of each at different temperature. It was concluded that the gemifloxacin existed four pseudo polymorphic forms and showed highest percentage drug release than the amorphous form.

  4. Formulation and evaluation of sustained release matrix tablets of nifedipineDownload Article

    Eswar kumar.A, A.Vaishnavi, S.Ayesha, V.Saritha, M. Radhika
    • Article Type: Research Article
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    • Pages (219-228)
    • No of Download = 1584

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    Nifedipine is a calcium channel blocker, which has short half-life, makes the development of sustained release (SR) dosage form. The present work was to formulate a sustained release matrix dosage form of Nifedipine by using hydrophilic polymer (HPMC) and hydrophobic polymer (Ethyl cellulose) to achieve better bioavailability and also to reduce dosing frequency and side-effects. Nifedipine matrix tablets were prepared by direct compression method. Formulated tablets were also characterized by parameters like thickness, weight variation test, drug content uniformity, hardness, friability and the in-vitro release rate profile was compared with the marketed product’s release profile. FT-IR spectra revealed that there was no interaction between drug and polymers. Tablets were subjected to In-Vitro drug release in 0.1 N HCl (pH 1.2) for first 2 hours followed by phosphate buffer (pH 6.8) for remaining 10 hours. From among all the developed formulations, NF2 formulation sustained the drug release for longer period of time as compared to other formulations. So, NF2 was selected as the best formulation. To know the drug release kinetics Zero order, First order, Higuchi plot, Korsmeyer Peppa’s plot were constructed. For optimized formulations zero order plot showed linearity with high regression coefficient values than the first order. According to ‘n’ values obtained from the Korsmeyer peppa’s plot it may be concluded that the drug release is by fickian transport and drug release was controlled by diffusion mechanism.

  5. Herbs Combating with Inflammation- A ReviewDownload Article

    Ms.Suchita V.Ghumre, Dr. (Mrs) Varsha M. Jadhav, Dr (Mr) Vilasrao J. Kadam
    • Article Type: Review Article
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    • Pages (229-243)
    • No of Download = 864

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    Inflammation is a component of the intricate biological replication of vascular tissue to deleterious stimuli such as pathogens, damaged cells or irritants. The major anti-inflammatory drugs available are NSAIDS, but due to their rigorous side-effects such as GI bleeding, ulcers, stomach upset their utilization has been constrained. Therefore to surmount the side-effects, revelation of potent NSAIDS with very low or no gastro-intestinal side-effects is the area of prime paramountcy. As a result of innate quandary associated with NSAID’s there is perpetual search for alternative agents, especially from natural sources. Several herbal drugs constitute a paramount avenue for inflammation and rheumatoid arthritis that obviates structural damage of arthritic joint caused by tissue or bone breakdown. Additionally it is safe, inexpensive, highly abode and convenient for many patients.

  6. RP-HPLC method development and validation for the simultaneous estimation of ramipril and losartan in tablet and pharmaceutical dosage formDownload Article

    K.Pallavi, Pranitha ,K.Sampath Kumar
    • Article Type: Research Article
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    • Pages (244-255)
    • No of Download = 1692

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    A simple reversed-phase high-performance liquid chromatographic (RP-HPLC) method has been developed and validated for simultaneous determination of Ramipril and Losartan in pharmaceutical tablet dosage form. Chromatographic analysis was performed on a Inertsil ODS (250×4.6× 5µ)column at ambient temperature with a mixture of 10mM KH2PO4:ACN (30:70) v/v (1.36gm of potassium di hydrogen phosphate (KH2PO4) was weighed and dissolved in 1000ml of water and volume was made up to 1000ml with water. Adjust the pH to 3.0 using ortho phosphoric acid. The buffer was filtered through 0.45µ filters to remove all fine particles and gases) as mobile phase, at a flow rate of 1.0 ml/min-1. UV detection was performed at 211 nm. The method was validated for accuracy, precision, specificity, linearity and sensitivity. The retention times of Ramipril and Losartan were 2.667 and 3.887 min, respectively. Calibration plots were linear over the concentration ranges 3-7 μg mL-1 and 60-140 μg mL-1 for Ramipril and Losartan, respectively. The Limit of detection was 0.24 and 1.09 µg mL-1 and the quantification limit was 0.72 µg mL-1 and 3.30 µg mL-1 for Ramipril and Losartan, respectively. The accuracy of the proposed method was determined by recovery studies and found to be 100.12% to 100.43%. Commercial tablet formulation was successfully analyzed using the developed method and the proposed method is applicable to routine analysis of determination of Ramipril and Losartan in pharmaceutical tablet dosage form.

  7. Overview on transdermal drug delivery by semisolid systems: EmulgelDownload Article

    Vinod V, and CH S Vijaya Vani
    • Article Type: Review Article
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    • Pages (256-263)
    • No of Download = 1114

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    When gels and emulsions are used in combined form the dosage forms are referred as emulgels. In recent years, there has been great interest in the use of novel polymers with complex functions as emulsifiers and thickeners because the gelling capacity of these compounds allows the formulation of stable emulsions and creams by decreasing surface and interfacial tension and at the same time increasing the viscosity of the aqueous phase. In fact, the presence of a gelling agent in the water phase converts a classical emulsion into an emulgel. Both oil-in-water and water-in-oil emulsions are used as vehicles to deliver various drugs to the skin. Emulsions possess a certain degree of elegance and are easily washed off whenever desired. They also have a high ability to penetrate the skin. Emulgels for dermatological use have several favorable properties such as being thixotropic, greaseless, easily spreadable, easily removable, emollient, nonstaining, water-soluble, longer shelf life, bio-friendly, transparent & pleasing appearance.

  8. An overview on multiparticulate drug delivery system: PelletsDownload Article

    D. Sandeep, Sowjanya Battu
    • Article Type: Review Article
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    • Pages (264-275)
    • No of Download = 1150

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    Pellets can be defined as small, free flowing, spherical or semi-spherical solid units, typically from about 0.5 mm to 1.5 mm, and intended usually for oral administration, manufactured by the agglomerates of fine powders or granules of bulk drugs and excipients using appropriate processing equipment. Pellets can be prepared by many methods, the compaction and drug-layering being the most widely used today. Regardless of which manufacturing process is used, pellets have to meet the following requirements. They should be near spherical and have a smooth surface; both considered optimum characteristics for subsequent film coating. Pellets may have varied applications in varied industries. It just requires an innovative bend to use it to derive maximum profitability. The smooth surface & the uniform size of the pellets allow uniform coating not only for each pellet but also from batch to batch.

  9. Review on topical gellified emulsion: Superior vehicle for hydrophobic drugsDownload Article

    G. Nandini, B. Sirisha
    • Article Type: Review Article
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    • Pages (276-281)
    • No of Download = 861

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    When gels and emulsions are used in combined form the dosage form are referred as emulgel. In recent years, there has been great interest in the use of novel polymers. Emulgel is an emulsion, either of the oil-in-water or water-in-oil type, which is gelled by mixing with a gelling agent. Emulgel shows dual release control system of the gel and emulsion. Many advantages of gels a major limitation is in the delivery of hydrophobic drugs. So to overcome this limitation an emulsion based approach is being used so that even a hydrophobic therapeutic moiety can enjoy the unique properties of gels. The emulgel for dermatological use has several favorable properties such as being thixotropic, greaseless, easily spreadable, easily removable, emollient, non-staining, water-soluble, longer shelf life, bio-friendly, transparent & pleasing appearance. The bioavailability of an emulgel can be enhanced by using permeation enhancers. The use of emulgel can be extended to analgesic, antifungal drugs & various cosmetic formulations.

  10. Development and validation of RP-HPLC method for simultaneous estimation of hydrochlorothiazide and thiocolchicoside in bulk and in a synthetic mixtureDownload Article

    Nagunath S, Alekya, Priyanka, Srivani, Pallavi, Rajeshekar, vennela
    • Article Type: Research Article
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    • Pages (282-290)
    • No of Download = 714

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    A simple, rapid and precise reverse phase liquid chromatographic (RP-HPLC) method was developed and subsequently validated for simultaneous estimation of Hydrochloro thiazide (HCT) and Thiocolchicoside (TCS) in bulk drug and in a synthetic mixture. The analysis was carried out using Zodiac ODS C18 (4.6 x 250mm, 5µm, Make: Zodiac Life Sciences), pre-packed column. The separation was carried out using a mobile phase containing a buffer of pH 4.0, Acetonitrile (80:20 v/v), was pumped at a flow rate of 1.2 mL/min with UV-detection at 267 nm. Both the drugs were well resolved on the stationary phase and the retention times were around 5.170 minute for Hydrochloro thiazide and 7.477 minute for Thiocolchicoside. The method was validated and shown to be linear for Hydrochloro thiazide and Thiocolchicoside. The correlation coefficients for Hydrochloro thiazide and Thiocolchicoside are 0.997 and 0.999 respectively. The relative standard deviations for five replicate measurements in two sets of each drug in the tablets is always less than 2% and mean % error of active recovery not more than ±1.5%. The method was validated for precision and accuracy. The proposed method was successfully applied to the synthetic mixture containing the above-mentioned drug combination without any interference by the excipients.

  11. Review article on microspheresDownload Article

    Priya Shukla, CH.S.Vijaya Vani
    • Article Type: Review Article
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    • Pages (291-301)
    • No of Download = 459

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    Microspheres are characteristically free flowing powders consisting of proteins or synthetic polymers having a particle size ranging from 1-1000 µm. The range of Techniques for the preparation of microspheres offers a Variety of opportunities to control aspects of drug administration and enhance the therapeutic efficacy of a given drug. There are various approaches in delivering a therapeutic substance to the target site in a sustained controlled release fashion. One such approach is using microspheres as carriers for drugs also known as microparticles. It is the reliable means to deliver the drug to the target site with specificity, if modified, and to maintain the desired concentration at the site of interest. Microspheres received much attention not only for prolonged release, but also for targeting of anticancer drugs. In future by combining various other strategies, microspheres will find the central place in novel drug delivery, particularly in diseased cell sorting, diagnostics, gene & genetic materials, safe, targeted and effective in vivo delivery and supplements as miniature versions of diseased organ and tissues in the body.

  12. REVIEW ARTICLE ON MICROPARTICLESDownload Article

    Shivani, Sujitha.H
    • Article Type: Review Article
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    • Pages (302-309)
    • No of Download = 1092

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    Recent drug discovery using advanced techniques such as genomics, combinatorial chemistry, high throughput screening and in silico three dimensional drug design has yielded drug candidates with low water solubility and thus an inherently low mucosal permeability which makes the development of pharmaceutical formulations difficult. To overcome these, particulate systems like microparticles have been used as a physical approach to alter and improve the pharmacokinetic and pharmacodynamics properties of various types of drug molecules. They have been used in vivo to protect the drug entity in the systemic circulation, restrict access of the drug to the chosen sites and to deliver the drug at a controlled and sustained rate to the site of action. Various polymers have been used in the formulation of microparticles for drug delivery research to increase therapeutic benefit, while minimizing side effects. The review embraces various aspects of microparticle formulations, characterization, effect of their characteristics and their applications in delivery of drug molecules and therapeutic genes.

  13. An overview on buccoadhesive drug delivery system: tool to enhance bioavailabilityDownload Article

    *Garika Swapna, Sharadha Srikanth
    • Article Type: Review Article
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    • Pages (310-320)
    • No of Download = 551

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    Oral cavity is the foremost part of digestive system of human body due to its excellent accessibility and reasonable patient compliance, oral mucosal cavity offers attractive route of drug administration for the local and systemic therapy. The purpose of the buccal tablet is absorption of the drug through the lining of the mouth. Buccal tablets can be most easily held between the gum and cheek. Various drugs have been investigated for their delivery through the buccal mucosa in a mucoadhesive buccal tablet form.

  14. A Review on Multilayer TabletsDownload Article

    *Md. Riyaz, R.Shireesh Kiran, V.Uma maheshwar rao
    • Article Type: Review Article
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    • Pages (321-326)
    • No of Download = 1079

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    Oral drug delivery has been known for decades as the most widely utilized route of administration among all routes that have been explored for the systemic delivery of drugs in case of different dosage forms. Multilayer tablets are tablets made by compressing several different granulations fed in to a die in succession, one on top of another, in layer. Each layer comes from a separate feed frame with individual weight control. Rotary tablet presses can be set up for 2 or 3 layers. More are possible but the design becomes very special. Ideally a slight compression of each layer and individual layer ejection permits weight checking for control purposes.

  15. Diabetic Ketoacidosis - A Review And UpdateDownload Article

    Manu Jose, Sundararaman Sheshadri, Rajalakshmi Mathialagan, Dilip Krishnan, Arun Ramachandran, Babin Dhas Reejo*
    • Article Type: Review Article
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    • Pages (327-333)
    • No of Download = 992

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    Diabetic ketoacidosis (DKA)is a life-threatening acute metabolic complication of diabetes mellitus caused by complete lack of insulin in type 1diabetes mellitus or inadequate insulin levels associated with stress or severe illness either in type 1 or type 2 diabetes mellitus. The onset of diabetic ketoacidosis varies considerably (between 15% and 67%) from one country to another. DKA is responsible for more than 500,000 hospital days per year at an estimated annual direct medical expense and indirect cost of 2.4 billion USD. Severe depletion of water and electrolytes from intra- and extracellular fluid compartments characterizes DKA. The key diagnostic feature in DKA is the elevation in circulating total blood ketone concentration. Treatment includes fluid replacement, insulin therapy, potassium replacement, bicarbonate therapy and phosphate therapy.As diabetes mellitus is increasing rapidly; more awareness is needed to care diabetic’s complications such as DKA. Of diabetic complications, sudden deaths are mostly caused by DKA. In the past few decades standardized care and studies decreased the mortality of DKA. The prevention of DKA will require further study as well as patient education.The aim of this review is to find the cause, symptoms and treatment ofDKA, also to make aware of DKA.

  16. FORMULATION AND IN-VITRO EVALUATION OF MICROSPHERES EMBEDDED WITH CAPECITABINEDownload Article

    *V.Shivani, C.Radhika, V.Uma Maheshwar Rao
    • Article Type: Research Article
    • View Abstract
    • Pages (334-351)
    • No of Download = 1067

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    Recent drug discovery using advanced techniques such as genomics, combinatorial chemistry, high throughput screening and in silico three dimensional drug design has yielded drug candidates with low water solubility and thus an inherently low mucosal permeability which makes the development of pharmaceutical formulations difficult. To overcome these, particulate systems like micro particles have been used as a physical approach to alter and improve the pharmacokinetic and pharmacodynamics properties of various types of drug molecules. They have been used in vivo to protect the drug entity in the systemic circulation, restrict access of the drug to the chosen sites and to deliver the drug at a controlled and sustained rate to the site of action. Various polymers have been used in the formulation of micro particles for drug delivery research to increase therapeutic benefit, while minimizing side effects. The review embraces various aspects of micro particle formulations, characterization, effect of their characteristics and their applications in delivery of drug molecules and therapeutic genes.

  17. Formulation and evaluation of double walled microspheres of esomeprazoleDownload Article

    Priya Shukla*, Ch.S.Vijayavani, V.Uma Maheshwar Rao
    • Article Type: Research Article
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    • Pages (352-364)
    • No of Download = 1421

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    The present study involves the preparation of double walled microspheres of Esomeprazole sodium. Esomeprazole microspheres are mainly designed to achieve constant release of the drug over long periods of time. Preformulation studies were carried out before formulation design. Total seven formulations were prepared using two different polymers viz., Hydroxy Propyl Methyl Cellulose and sodium alginate in various ratios. Microspheres were discrete, spherical, and free-flowing and showed a good percentage of drug entrapment efficiency. FT-IR spectraof the physical mixture revealed that the drug is compatible with the polymers and copolymer used. In-vitro dissolution test was carried out. All the formulations showed good dissolution profiles. Among all the formulation F6 showed good dissolution profile with 97.80% of drug release in 12 hours. . In-vitro release kinetic data of Esomeprazole microspheres showed that the drug release follows showed that the drug release from the formulations followed the Non fickian diffusion mechanism and follows zero order kinectics.Stability studies were done for the selected formulation which indicates that there is no change in drug content of the formulation. Based on the results of evaluation tests formulation coded F6 was concluded as best formulation. The results of this investigation indicate that Ion gelation method can be successfully employed to fabricate Esomeprazole microspheres.

  18. Method development and validation of amiodarone in bulk and pharmaceutical dosage form by RP-HPLCDownload Article

    S. S. Patil*, Y. H. Shaikh, C. V. Panchal, S. J. Wakode, B. N. Poul
    • Article Type: Research Article
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    • Pages (365-380)
    • No of Download = 1298

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    A simple rapid sensitive, precise method has been developed for the estimation of amiodarone in pharmaceutical dosage form (Injection) using Hypersil BDS C18 column (150mm×4.6mm) 5µm, used for the separation. The mobile phase consisting of Acetonitrile: Triethylamine buffer (75:25) of pH 6.5 adjusted with ortho-phosphoric acid. The conditions optimized were: flow rate (2 ml/minute), wavelength (240 nm) and run time was 10min. This method is validated for System suitability, Specificity, Accuracy, Linearity, Range and Robustness. The precision was calculated as repeatability, inter and intraday variation (%RSD) for the drug and met all specifications as per ICH guidelines. The proposed method is good for obtaining reliable results and found to be suitable for the routine analysis in amiodarone in pharmaceutical dosage form.

  19. A Simple Validated RP-HPLC Method for Quantification of Azilsartan Medoxomil in Bulk and Pharmaceutical Dosage FormsDownload Article

    Jampala Balaji*, Bandi Ramachandra, Niranjan and N.V.S.Naidu
    • Article Type: Research Article
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    • Pages (381-385)
    • No of Download = 545

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    A simple reverse phase high performance liquid chromatography method developed for quantification of Azilsartan Medoxomil in bulk and pharmaceutical dosage forms. This method achieved by using isocratic elution with mixed phosphate buffer (pH: 6.8 ± 0.1) and acetonitrile mobile phase at 80:20 ratio, Zodiac C18 column (100 X 4.6mm, 3µm) at temperature 30ºC, flow rate 1.0mL/min and 243nm UV-Visible detector. This method validated as per ICH guidelines. This method was simple, specific, precise, linear, accurate, robust and ruggedness for analysis of Azilsartan Medoxomil.

  20. Validation of lodhradi kashaya (Ayurvedic formulation) made by traditional method and contemporary spray drier method through FTIR spectroscopyDownload Article

    Varun Kumar Singh, K R C Reddy*
    • Article Type: Research Article
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    • Pages (386-390)
    • No of Download = 1345

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    Lodhradi Kashaya is a classical formulation mentioned in Vaidya Chintamani under Kaphaj prameha and also in Basavarajiyam under prameha prakarana. The therapeutic efficacy of the Lodhradi Kashaya was described as ‘Madhumehajeet’, i.e. win over Diabetes Mellitus. In the classical wisdom, it was indicated to administer as decoction but in present fast moving and taste driven world it is difficult to made decoction each time. So here an approach was made to modify the decoction dosage form in to spray dried powder that again can be easily converted to decoction just by dissolving suitable quantity of dosage form in appropriate amount of water. To validate the spray dried powder of Lodhradi Kashaya, two sample was made one from spray drier (LKSD) following the continuous complete aqueous extraction and second in laboratory (LKLB) following traditional method to prepare decoction and dried to form powder. Both the sample were analysed by FTIR spectroscopy. Absorbance pattern in the IR spectra indicate that there is no significance variation found in LKLB and LKSD. The peaks were found similar in pattern and the absorbance corresponding to the allotted chemical interactions was similar which reflects that both the sample was similar in their chemical composition. This study presents the data showing the chemical similarities between classical method of preparation and contemporary machinery involvement. It is also step in the field of commercialization of kwath kalpana in modified dosage form and it is the need of time to make low cast, stable drugs that will be easy in distribution and administration.

  21. Simultaneous RP-HPLC determination of abacavir, lamivudine and dolutegravir in bulk API dosage formsDownload Article

    M.Monica and D.Gowri Sankar
    • Article Type: Research Article
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    • Pages (391-398)
    • No of Download = 1704

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    The RP-HPLC method was developed and validated for the determination of a combination of Abacavir, Lamivudine and Dolutegravir in bulk API forms. The chromatography was carried out on Agilent C18 column (100mm x 4.6mm, 3.5µ) using a mobile phase of Ammonium formate and methanol in the ratio of 40:60, at a flow rate of 0.8ml/minute. The analytes were monitored at 262nm using a PDA detector. The retention time of Abacavir, Lamivudine and Dolutegravir were observed at 1.73, 1.30 and 4.32 minutes respectively. The developed method was found to be linear in the concentration range of 5µg-50µg having r2 value of 0.999, 0.999 and 0.998 for Abacavir, Lamivudine and Dolutegravir respectively. The method has been validated according to ICH guidelines.

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