Analytical Method Development for Drugs and Impurities Degradation Using Chromatography Technique
Keywords:
HPLC, Famotidine, Degradation, Impurity Detection, Method Development, Validation, Pharmaceutical AnalysisAbstract
High Performance Liquid Chromatography (HPLC) is a powerful technique which helps in development and validation of analytical methods for drug analysis, including degradation studies. The paper focuses on the application of HPLC for analysis of drug impurities and degradation products. The experimental result demonstrates the robustness, accuracy, sensitivity of HPLC method for detection of degraded products and identifying impurities in pharmaceutical drugs. The method was validated according to ICH guidelines for precision, linearity, specificity, accuracy, and robustness. The study concludes on the method being suitable for regulatory compliance and quality assurance in the pharmaceutical industry.
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