IJPAR | International Journal of Pharmacy and Analytical Research

International Journal of Pharmacy and Analytical Research

ISSN: 2320_2831

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  1. Formulation, characterization and Evaluation of Transdermal Film Containing NaproxenDownload Article

    Y.Phalguna, Ch.Shivalumar, N.Suresh, B.Mahender, Ch.Prakasham
    • Article Type: Research Article
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    • Pages (121-126)
    • No of Download = 1116

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    Transdermal drug delivery system has numerous advantages over the more traditional drug delivery systems. This includes high bioavailability, steady drug plasma concentration, absence of first pass hepatic metabolism effect. Transdermal film is an adhesive film that has a coating of a drug that is placed on the skin to deliver a specific dose of the drug into the bloodstream over a period. The aim of present study an attempt was made to design the transdermal drug delivery system of naproxen with Ethyl Cellulose polymer in various concentrations. Transdermal films were prepared by solvent casting method by using Dibutylpthalate as plasticizer. The prepared films were characterized in physical appearance, thickness, drug content, weightvaration, Folding endurance, percentage moisture uptake and in-vitro release study.

  2. Analytical method development and validation of Glimepiride in bulk and tablet dosage form using UV SpectrophotometerDownload Article

    V Asha Ranjani, C Abigna, D Akhilesh kumar, K Prashanthi, M Sindhuja
    • Article Type: Research Article
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    • Pages (127-133)
    • No of Download = 1506

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    The main objective of the study is to develop and validate an analytical method for quantitative determination of Glimepiride in bulk and tablet dosage form using UV-Visible Spectroscopy. The Glimepiride shows maximum absorption at 231nm and obeys Beer’s law in the range of 5-10µg/ml.For the method development we have selected a perfect solvent system using solvent such as NaOH. Calibration curve has been plotted. The assay should be carried and percentage recovery needs to be calculated. For the validation of the analytical method developed is carried out by determining parameters like Linearity, range, LOD, LOQ, Accuracy, Precision, Ruggedness.The calibration plot did not deviate from linearity because of its low intercept value, the LOD and LOQ values were found to be 25.93µg/ml and 86.44µg/ml respectively which shows the sensitivity of the method. The ruggedness is found to be less than 2%. The percentage recovery was assessed using 3 different solutions of 8.0, 10.0, 12.0 µg/ml and the results obtained were 98, 101.2, and 102% respectively. The developed method was applied to the quantification of Glimepiride in tablets available in local market. It can be seen that the results obtained by proposed method was very much similar to that of established methods.

  3. Chitosan Versatile Biodegradable Polymer and its Importance – ReviewDownload Article

    Pitchai Pillai M, Anbarasu D, Varatharajan R, Sriram N
    • Article Type: Review Article
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    • Pages (134-143)
    • No of Download = 502

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    Chitosan is a polysaccharide derived from renewable resources. Chitosan is a biodegradable, biocompatible, positively charged nontoxic mucoadhesive biopolymer. These unique features of chitosan have interested in development of delivery systems for a wide range of biological agents. The properties, biodegradability, and biological role of chitosan is frequently dependent on the relative proportions of N-acetyl-D-glucosamine and D-glucosamine residues. Sources of chitin are the shell wastes of crab, shrimp, lobster and crawfish etc. Chitosan is usually prepared by the deacetylation of chitin. It is having the biological activity like Haemostatic, Fungistatic, Spermicidal and accelerate the wound healing. It can be used in various drug delivery systems like mucoadhesive drug delivery, insulin oral drug delivery, colon drug delivery etc.It can be used in cosmetics preparation, and in agricultures used for growth and better yield.

  4. Nanotechnology based Oral Delivery of Insulin – A RetrospectDownload Article

    Balasubramanian J, Narayanan N, Mohan.V, Ranjit Mohan Anjana, Mandava Sree Bindu.
    • Article Type: Review Article
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    • Pages (144-150)
    • No of Download = 409

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    Nanotechnology provides novel innovative means to detect, diagnose, and treat disease. In this regard, numerous nanoparticles-based approaches have been taken in an effort to develop an effective oral insulin therapy to treat diabetes. This paper gives the clear information on formulation of solid oral dosage form of insulin using different types of polymers in Nanotechnology platform. In non-invasive therapy for Diabetes Mellitus oral delivery is still a exciting job in Novel drug delivery system, Since degradation of insulin due to presence of enzymes, pH changes in the gastrointestinal tract and absorption through the GI mucosa is doubtful. In oral delivery Nanotechnology based insulin formulations which improves the bioavailability, absorption and protect the insulin from enzymatic degradation. In nanotechnology based oral insulin drug delivery with high bioavailability, various practical approaches might be most helpful like protecting insulin from enzymatic degradation, use of penetration enhancers, chemical modification, Bioadhesive delivery system, use of nanoparticales to improve bioavailability of insulin. Despite, various techniques each having its own limitation and advantages, the oral route scores over the others for the ease of comfort with which the therapeutic agents can be administered to the patients work on attempts to deliver insulin orally has definitely gathered momentum and is no longer considered with pessimism to develop the oral insulin drug delivery system.

  5. Formulation and Evaluation of Gabapentin Mucoadhesive Gastro Retentive Tablets.Download Article

    M.Vikramaditya Reddy, Ch.S.Vijayavani, V.Uma Maheshwara Rao.
    • Article Type: Research Article
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    • Pages (151-163)
    • No of Download = 4318

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    The present research work was an attempt to Formulate and Evaluate Gabapentin Gastroretentive mucoadhesive tablets to prolong gastric residence time and increase drug absorption further increasing the bioavailability. The tablets were prepared by direct compression method using mucoadhesive polymers like Carbopol 934P, Sodium Carboxy Methyl Cellulose (SCMC), Sodium alginate along with other standard excipients like Microcrystalline cellulose, Magnesium stearate and Aerosil . FTIR studies confirmed the absence of any drug/polymers/excipients interactions. The prepared tablets were evaluated by different parameters such as Thickness, Weight variation, Hardness, Content Uniformity, Swelling Index and Mucoadhesive strength. Indigenously fabricated assembly was used to measure the Mucoadhesive strength of the Mucoadhesive tablets, and goat gastric mucosa was used as a model tissue. Mucoadhesive strength increased with increasing Polymer concentrations. The tablets were also evaluated for in vitro drug release in 0.1N HCl for 12 h in USP Type II dissolution apparatus. Among all the formulations (F-I to F-XII) prepared, batch F-IV (0.5% C-934P) gave relatively slow release of Gabapentin over 12 h when compared to other formulations The in-vitro data is fitted in to different kinetic models and the best-fit was achieved with the Peppas model. The optimized formulation F-IV followed Zero order release kinetics followed by non-fickian transport. Mucoadhesive tests assured the prolonged Gastro retention of tablets. It also showed no significant change in physical appearance, Drug content, Mucoadhesive strength or in-vitro dissolution pattern after storage at 450 C at 75 % RH for a period of 3 months.

  6. Formulation and Evaluation of Moxifloxacin Loaded Alginate Chitosan NanoparticlesDownload Article

    R.Devi damayanthi, C.B.Tharani, N.Narayanan.
    • Article Type: Research Article
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    • Pages (164-168)
    • No of Download = 426

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    The main objective of this study was to prepare and evaluate Alginate chitosan nanoparticles containing Moxifloxacin by ionic gelation method. The influence of different experimental parameters on the entrapment efficiency (EE), drug loading (DL), rate of recovery, percent drug released etc was evaluated. SEM indicated that nanoparticles have discrete spherical structure without aggregation. The average particle size was found to be 105.2±8nm. The in vitro drug release behaviour from all drug loaded batches was found to be sustained release over a period of 96 hours. Nanoparticles were stored at different temperatures and humidity as per ICH guidelines to check the stability.

  7. Analytical Method Development and Validation of Tolvaptan in Bulk and Tablet Dosage Form by RP-HPLCDownload Article

    B.Prathyusha, B.Shirisha, N.Ramathilagam, N.Sriram.
    • Article Type: Research Article
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    • Pages (169-174)
    • No of Download = 1635

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    A new, simple, accurate, precise, robust, specific, sensitive and rapid reverse phase high performance liquid chromatographic (RP-HPLC) method was developed and validated for the estimation of TOLVAPTAN in pharmaceutical dosage forms. A Nucleosil C18 with mobile phase containing 0.01M sodium dihydrogen phosphate and acetonitrile in the ratio of 60:40 was used. The flow rate was 0.6 ml / min and wavelength was monitored at 269 nm. Chromatogram showed the main peak at a retention time of 3.055 min. The developed method was validated according to ICH guidelines and validated for linearity, accuracy, precision, specificity, limit of detection, limit of quantification and robustness. The linearity was found to be in the range of 25 to 150 mcg / ml. respectively. Recovery of Tolvaptan was found to be in the range of 99.74-99.87% %.The system precision and method precision was found to be within limits with % RSD of 0.773 and 0.024% .The developed method was found to be cost effective and was successfully employed for the determination of the same in various formulations.

  8. Development and Validation of RP-HPLC Method for Simultaneous Estimation of Sitagliptin and Simvastatin in Bulk and Tablet Dosage FormDownload Article

    B.Shirisha, B.Prathyusha, N.Ramathilagam, J.Priya, N.Sriram.
    • Article Type: Research Article
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    • Pages (175-183)
    • No of Download = 1171

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    A simple reversed-phase high-performance liquid chromatographic (RP-HPLC) method has been developed and validated for simultaneous determination of Sitagliptin and Simvastatin in bulk and tablet dosage form. Chromatographic analysis was performed on a Nucleosil C18 (150X4.6 mm, 5µm) column ambient temperature with a mixture of phosphate buffer and Acetonitrile in the ratio 30:70 (phosphate buffer preparation; 0.01 N Potassium dihydrogen phosphate, pH 3.5 adjust with triethylamine) as mobile phase, at a flow rate of 1 mL min-1. UV detection was performed at 254 nm. The method was validated for accuracy, precision, specificity, linearity and sensitivity. The retention times of Sitagliptin and Simvastatin were 3.242 min and 6.492 min, respectively. Calibration plots were linear over the concentration ranges 25-150 μg mL-1 and 5-30 μg mL-1 for Sitagliptin and Simvastatin respectively. The Limit of detection was 1.305 µg mL-1 and 0.257 µg mL-1 and the quantification limit was 3.941µg mL-1 and 0.77µg mL-1Sitagliptin and Simvastatin for respectively. The accuracy of the proposed method was determined by recovery studies and found to be 99.20% to 100.94%.

  9. A validated RP-HPLC method for the simultaneous estimation of paracetamol and naproxen in bulk and tablet dosage formsDownload Article

    Krishanu Pal, V.Murali Balaram, M.Bhagavan Raju.
    • Article Type: Research Article
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    • Pages (184-193)
    • No of Download = 622

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    A simple, sensitive, accurate, precise, reproducible, specific and cost-effective RP-HPLC method was developed and validated for the simultaneous estimation of Paracetamol (PCM) and Naproxen sodium (NPX) in the bulk and pharmaceutical dosage forms. Chromatography was carried on a Nucleosil C8 (250 X 4.6 mm, 5μm) column with mobile phase comprising of phosphate buffer pH-6.5 adjusted with 1N potassium hydroxide and acetonitrile in the ratio of 70:30 v/v. The flow rate was adjusted to 1.0 ml/min with UV detection was carried out at 240 nm, and column temperature of 30±0.50 C was maintained throughout the study. The retention times for PCM and NPX were found to be 3.54 min and 4.59 min respectively. Linearity values were obtained in the range of 2.5-15 µg/ml for PCM and 2-12 µg/ml for NPX with correlation coefficient (r2) of 0.999 for both drugs. The method was validated as per ICH guidelines for specificity, linearity, precision, accuracy, robustness, limit of detection and limit of quantification. So the proposed method was found to be suitable for the routine quality control analysis of these drugs in raw materials and also in pharmaceutical dosage forms.

  10. Analytical method development and validation for residual solvent of Diltiazem hydrochloride extended release capsule by Gas chromatographyDownload Article

    Raja Sundararajan, Christopher Vasanth Kumar, Jayaveera.
    • Article Type: Research Article
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    • Pages (194-203)
    • No of Download = 457

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    Residual solvents are organic volatile chemicals that are either used or produced during the manufacture of active pharmaceutical ingredients, excipients, and drug products. Organic solvents such as di ethyl ether, N heptane, acetone, methyl acetate, tertiary - butyl alcohol, iso-propyl alcohol, ethanol , toluene, Nbutanol, and n-butyl acetate frequently used in pharmaceutical industry for the manufacturing of drug product Gas Chromatography method for the determination of residual solvent of Diltiazem Hydrochloride Extended Release Capsules for iso-propyl alcoholhas been carried out using this method.this method utilized Perkin Elmer clarus 580 GC Turbomatrix 40 Headspace sampler and DB-624, 30 m x 0.530 mm ID, 3.0 µm column was used with flame ionizationdetector (FID). The GC method for the determination of residual solvent of Diltiazem Hydrochloride Extended Release Capsules was validated. The method was found to be specific, precise, linear, accurate, rugged, robust and suitable for its intended use.

  11. Screening of analgesic and antipyretic properties on ethanolic extract of argemone mexicana linnDownload Article

    R. Sivakumar, K.L. Senhil kumar1, G. Arunachalam, S. Jayaraman
    • Article Type: Research Article
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    • Pages (204-209)
    • No of Download = 363

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    The aim of this study was to investigate the analgesic and antipyretic properties of ethanolic extract of Argemone mexicana Linn. Also, the Phytochemical screening was conducted and the extract showed the presence of flavonoids, alkaloids, terpenoids, tannins, and steroids. Analgesic and antipyretic effects of ethanolic extract of Argemone mexicana linn were investigated at doses of 50 mg/kg b.w. and 100 mg/kg b.w. using tail immersion and yeast-induced pyrexia tests. Oral administration of Argemone mexicana ethanolic extract produced significant (P<0.001) raised the pain threshold at different time of observation (0-150min) in comparison with control. Tested on yeast-induced pyrexia in rats, significantly (P<0.0001) reversed hyperthermia at different does level. The results of pharmacological studies performed in the present study suggest that the extract possesses potent analgesic and antipyretic effects.

  12. Design and characterization of nizatidine effervescent floating matrix tablets employing semisynthetic rate-retarding polymersDownload Article

    Farhat Fatima, Prakash Katakam
    • Article Type: Research Article
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    • Pages (210-220)
    • No of Download = 605

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    Nizatidine effervescent controlled release floating tablets employing three grades of HPMC K4M, HPMC K15M and HPMC K100M in four ratios (1:0.5; 1:1; 1:5 and 1:2) were prepared and evaluated. FTIR, DSC and XRD studies on the formulations showed no interaction of nizatidine with the polymers employed in the study. Most of the tablet formulations showed values within the official limit upon pre and post- compression evaluation. The type of polymer affected the drug release rate and the mechanism. Polymer swelling was crucial in determining the drug release rate flotation. A lesser FLT could be achieved by increasing the concentration and increasing the viscosity grade of the polymer. The optimized formulation (NS6) offered best controlled release along with floating lag time of 1.2 min and total floating time of >14 h. Good stability was observed for 3 months during accelerated stability studies. The optimized formulation NS6 employing nizatidine: HPMC K15M in the ratio of 1:1 showed sufficient release for prolonged period, the dose could be reduced and the possible incomplete absorption of the drug could be avoided.

  13. RP-HPLC Method Development and Validation of Dapagliflozin in Bulk and Tablet formulationDownload Article

    Jeyabaskaran.M, Prof.Rambabu.C and Dhanalakshmi.B
    • Article Type: Research Article
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    • Pages (221-226)
    • No of Download = 2547

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    The present work is concerned with application of simple, precise, accurate, reproducible and specific RP-HPLC method for estimation of dapagliflozin (DGF) in bulk and pharmaceutical dosage forms using an Hypersil BDS 250mm x 4.6 mm, 5 column in isocratic mode with 0.1% Ortho phosphoric acid buffer and acetonitrile 50:50 % v/v as mobile phase at a flow rate of 1ml/min. The injection volume was 10 µl and the total runtime was set as 5min. The determination of analytes was carried out at 245nm using PDA detector. The retention time for DGF was found to be 2.226min. The proposed method has permitted the quantification of DGZ over linearity in the range of 25 – 150 µg/ml and its percentage recovery was found to be 100.12 %. The % RSD of intraday and inter day precision were found 0.6% and 0.29%.

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