IJPAR | International Journal of Pharmacy and Analytical Research

International Journal of Pharmacy and Analytical Research

ISSN: 2320_2831

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  1. Development and Validation of RP – HPLC Method for the estimation of Oxyclozanide in Pure and Pharmaceutical formulationDownload Article

    Anusha.G, T.Rattaiah Guptha, S.Manohar Babu.
    • Article Type: Research Article
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    • Pages (185-191)
    • No of Download = 915

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    A simple, fast, precise, selective and accurate RP-HPLC method was developed and validated for the simultaneous determination of oxyclozanide from pharmaceutical formulation. Chromatographic separation was achieved gradient on a YMC c18 column (250 x 4.6 mm, 5 µ particle size) using a mobile phase acetonitrile and water in the ratio of 80:20.the flow rate was 1.0ml / min and effluent was detected at 300nm.the retention time of oxyclozanide was found to be 1.89min. Linearity was observed in the concentration range of 10 -100µg / ml .The method was validated according to ICH guidelines with respect to specificity, linearity, accuracy, precision and robustness. The method developed can be used for the routine analysis of oxyclozanide.

  2. Method Development and Validation of Related Substances by HPLC for Analysis of Valacyclovir Hcl in valacyclovir Hcl Tablet FormulationsDownload Article

    B.Bhagyalaxmi, Sundararajan Raja, I.Kishore Kumar.
    • Article Type: Research Article
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    • Pages (192-201)
    • No of Download = 634

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    A simple, sensitive, and precise high performance liquid chromatographic method for the impurities profiling of Valacyclovir Hcl tablets has been developed, validated and used for the determination of impurities in commercial pharmaceutical products. The Impurities were well separated on a Zorbax SB Phenyl column (250 mm X 4.6 mm, 5μm) by the gradient program using Triflouro acetic acid, Acetonitrile, methanole Methanolic HCl at a flow rate of 1.0 mL min-1 with detection wavelength at 254 nm. The developed method was found to be specific, precise, linear, accurate. LOQ Values for all the known impurities were below reporting thresholds.

  3. An Experimental Design Approach for Method Development and Impurity Profiling of Simvastatin by UV Spectrophotometric and RP–HPLC MethodsDownload Article

    Prakash Katakam, Baishakhi Dey, Nagiat T. Hwisa, Fathi H. Assalah, Narayan N. Rao, Babu R. Chandu, Analava Mitra
    • Article Type: Research Article
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    • Pages (202-213)
    • No of Download = 649

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    Analytical method development is a vital part of pre-formulation and formulation development research. Development of validated, robust, cost-effective methodologies for routine drug estimations is the urgent need of the pharmaceutical R&Ds. Quality is an essential attribute in any pharmaceutical product and impurity profiling offers a broad scope with the changed perspectives of the research scenario. The present work aims to devise a validated UV-spectroscopic and RP–HPLC method for estimations of SVN in bulk and formulations and impurity profiling of SVN related impurities at the specification limit with the aid of response surface methodology. The percent assay for SVN determined by UV method was 100.4±0.15 and mean %recovery was achieved to be 99.87±0.19. The percent assay of SVN by RP-HPLC method was found to be 100.14±0.1. The mean percent recovery at different spike levels (50–150%) ranged from 97.3±0.01–100.5±0.02 and the %RSD of assays at lower and higher spike levels were 1.4 and 0.3 respectively. The linearity data of impurities (A–G) at different spike levels (25, 50, 100, 125 and 200 µg) showed a high correlation coefficient of 0.99 in all cases. Percent mean recovery of impurities (A–G) at different spike levels comply the acceptance criterion. All other validation parameters also comply within the range of acceptable limits. The impurities were well separated with good resolution and peak shape, good retention times. The robustness of the developed HPLC method and that of impurity profiling was optimized applying Box-Benkhen experimental design approach.

  4. Development and validation of RP – HPLC method for the estimation of Tylosin tartrate in pure and pharmaceutical formulationDownload Article

    Sailaja Kotha, N.Sunitha, S.Manoharbabu.
    • Article Type: Research Article
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    • Pages (214-221)
    • No of Download = 2529

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    A simple, fast, precise, selective and accurate RP-HPLC method was developed and validated for the simultaneous determination of tylosin tartrate from pharmaceutical formulation. Chromatographic separation was achieved gradient on a phenomenex c18 column (250 x 4.6 mm, 5 µ particle size) using a mobile phase. Acetonitrile and water in the ratio of 90:10.the flow rate was 1.5ml / min and effluent was detected at 292 nm. The retention time of tylosin tartrate was found to be 2min. linearity was observed in the concentration range of 50 -250µg /ml. The method was validated according to ICH guidelines with respect to specificity, linearity, accuracy, precision and robustness. The method developed can be used for the routine analysis of tylosin tartrate.

  5. Formulation and Evaluation of Microspheres Containing AceclofenacDownload Article

    Y.Phalguna, G.Supriya, A.Tejasvi, D.Narasimha, G.Gopala Krishna.
    • Article Type: Research Article
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    • Pages (222-227)
    • No of Download = 641

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    Aceclofenac, a non-steroidal anti-inflammatory drug (NSAID) The chemical name of aceclofenac is Glycolic acid, [o(2,6 dichloroanilino) phenyl] acetate. Adverse effect of aceclofenac is headache, nausea, vomiting, bone marrow problems, dizziness constipation. Elimination half-life is 4 hrs. The main objective of this research work was to prepare hydroxyl propyl methyl cellulose and eudragit microspheres loaded with aceclofenac and invtro relese study.In the present study, solvent evaporation method is used for preparation microspheres. The polymers hydroxylpropyl methylcellulose and eudragit was dissolved and added to the 0.2% PVA solution and stirred it for 2 hrs. Microspheres were spherical shape and smooth surface. Infrared spectra showed identical peaks of drug and polymers. Drug entrapment efficiency was found to be (72.32%). In vitro release studies were performed by using shaking flask method about (89.59 %) drug was released in 12 hrs.

  6. Method development and validation for the estimation of metronidazole in tablet dosage form by UV spectroscopy and derivative spectroscopyDownload Article

    K.Narendra reddy and MK.Ranganath
    • Article Type: Research Article
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    • Pages (228-232)
    • No of Download = 523

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    Two simple, precise, rapid, sensitive and accurate spectrophotometric methods have been developed for the estimation of metronidazole in pure form and in tablet dosage form. Metronidazole has absorbance maxima at 313 nm in methanol: water (80:20) for UV spectroscopy and absorbance minima at 298nm for first order derivative spectroscopy. The linearity was obtained and obeyed Beer’s law in the concentration range of 4 - 12 μg/ml and correlation coefficients were 0.9995 and 0.9897 for UV spectroscopy and derivative spectroscopy respectively. The precision values for UV and derivative spectroscopy were found to be 0.35-0.64 and 1.78-1.92 with mean accuracies 98.60-99.70% and 97.55-103.80% respectively. Limit of detection values for UV and derivative spectroscopy were found to be 0.23 and 1.01 respectively. Limit of quantification for both UV and derivative spectroscopy were found 0.69 and 3.06 respectively. The methods were validated as per the International Conference on Harmonization (ICH) guidelines. The proposed validated methods were successfully used for the quantitative analysis of API and tablet dosage form.

  7. Quantitative estimation and validation of isotretinoin in Pharmaceutical dosage forms by RP-HPLCDownload Article

    T.Thirumalai Selvi, A.Chenthilnathan, V.V.Kamalakkannan.
    • Article Type: Research Article
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    • Pages (233-240)
    • No of Download = 664

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    Isotretinoin is a topical keratolytic agent which is used in the treatment of skin diseases including acne vulgaris. This paper deals with a simple, feasible and sensitive reverse-phase high-performance liquid chromatographic method for the quantitative determination of isotretinoin in pharmaceutical capsule dosage form. The chromatography was carried out by using HPLC system (Shimadzu LC2010HT) with UV- Visible dual absorbance detector (PDA), C18, 25 cm X 4.6 mm, 5 µm. The mobile phase consisting of 0.3% glacial acetic acid and water in the ratio of 85:15 and tetrahydrofuran and methanol used a diluent in the ratio of 20:80. The detection was made at 355 nm and the mobile phase flowed at 1 ml/min. Validation parameters included system suitability, specificity, linearity, accuracy precision (repeatability & reproducibility), robustness, ruggedness and stability were determined according to the ICH guidelines. The retention time of isotretinoin was found to be 12.33 min. Hence, the method could be successfully applied for routine analysis of isotretinoin in pharmaceutical dosage forms.

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