International Journal of Advances in Pharmaceutical Analysis

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Published by: Scholar Science Journals

Subjects: Pharmaceutical Science

Our mission is to advance the science and practice of pharmaceutical analysis by working to develop and maintain competence, ethics and integrity and the highest professional standards in the specialty for the benefit of the public. The Faculty seeks, through its activities, to bring about an improvement in the health of the public. The areas of interest of International Journal of Pharmaceutical Analysis are: * Analytical Research and Development * Analytical Services for Medical Devices * Chemical Imaging * Instrumentation * Comparator Studies * Drug analysis * Elemental Analysis and Trace Metals * GLP & GMP Method Development, Validation and Remediation * NMR Analysis for Pharmaceuticals * NMR Analysis for Counterfeit Drugs * Pharmaceutical Auditing * Physical Characterization Techniques for Pharmaceuticals * Stability and Pharmaceutical Testing


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ISSN No. :    2277-9353
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Implementing Quality by Design-A methodical approach in the RP-HPLC method development process

The concept of quality by design (QbD) has recently been adopted for the development of pharmaceutical processes to ensure a predefined product quality. Focus on applying the QbD concept to analytical methods has increased as it is fully integrated within pharmaceutical processes and especially in the process control strategy. Quality by design (QbD) refers to the achievement of certain predictable quality with desired and predetermined specifications. The QbD based method development helps in generating a design space and operating space with knowledge of all method performance characteristics and limitations and successful method robustness within the operating space. A very useful component of QbD is the understanding of factors and their interaction effects by a desired set of experiments. For the purpose of QbD for HPLC methods, robustness and ruggedness should be verified early in the method development stage to ensure method performance over the lifetime of the product. Quality-by-Design principles are applied to build in a more scientific and risk-based multi-factorial approach to the development and validation of analytical methods using HPLC

Review: common trouble shooting problems in RP-HPLC

High performance liquid chromatography is one the powerful analytical tool regularly employed for the analysis of the drugs in the pharmaceutical formulations. Day by day advancement in instrumentation is increasing but still the problems have been encountered while performing analysis. Here in this review article different troubleshooting has been described with their causative and preventive parameters during performing the method development for separation and identification by RP-HPLC.

Development of validated stability indicating assay method for simultaneous estimation of Diclofenac Sodium and Misoprostol in their combined dosage form

UV-Spectrophotometric Determination of Telmisartan and Hydrochlorothiazide in Combined Tablet Dosage Form Using Simultaneous Equation Method

A UV spectrophotometric method was developed for the estimation of Telmisartan & Hydrochlorothiazide in Combined Tablet Dosage Form Using Simultaneous Equation Method. The drug obeyed the Beer’s law & shows good correlation near to r2 = 0.999 for Telmisartan & for Hydrochlorothiazide r2=0.999.Absorption maxima of Telmisartan 296.8 nm and Hydrochlorothiazide 271.2 nm. Beer’s law was obeyed in concentration rang of 5-30 µg/ml for Telmisartan & 2-12 µg/ml for Hydrochlorothiazide. The method has been validated for linearity, accuracy & precision. The recovery was 99.28 % for Telmisartan & 99.26% for Hydrochlorothiazide. The developed method was found to be accurate, simple, precise, economical, and selective for simultaneous estimation of Telmisartan & Hydrochlorothiazide in tablet formulations.

Development of validated UV spectrophotometric method for the simultaneous estimation of metformin hydrochloride and glipizide in tablet dosage form

Development of validated stability indicating assay method for the simultaneous estimation of hydrochlorothiazide Amlodipine besylate and Losartan potassium in combine dosage form

A Stability indicating Reverse-Phase liquid chromatographic method for the simultaneous estimation of HCTZ, LOSA and AMLO was developed. The chromatographic assay involves the use of SUPELCO LC-8-DB column (15 cm x 4.6 mm, 5 µm) with a simple mobile phase composition of Buffer (monobasic Potassium Dihydrogen phosphate of 0.025 M having pH 3.7): Acetonitrile (60:40) at a flow rate of 1mL/min with U.V detection at wavelength of 232 nm. The method showed good linearity in the concentration range of 4-40 μg/mL for HCTZ and 2-22 μg/mL for AMLO and 15-150 μg/mL for LOSA. The proposed method was also successfully applied to 20 tablets of marketed formulation (Trilopace). The developed method was successfully validated as per the ICH guidelines for following parameters. Accuracy, precision, ruggedness, robustness, system suitability tests, etc. The RSD for system precision was found to be 0.89-0.49 for HCTZ, AMLO, and LOSA and for method precision 1.0-1.4 for HCTZ, AMLO, and LOSA. The average percentage recoveries 99.75, 99.88, 98.93 for HCTZ, AMLO, LOSA which was in good agreement with labeled amount of Pharmaceutical formulation. The stability indicating capacity was tested by accelerated degradation of marketed formulation in acidic (0.1 N HCL), basic (0.1 N NaOH), , Oxidative (3% H2O2), Thermal (800C)

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