Abstract
High Performance Thin layer Chromatography (HPTLC) technique is a sophisticated and automated form of the thin-layer chromatography (TLC) with better and advanced separation efficiency and detection limits. The analytical method should be sensitive, specific, fast and accurate to establish the assurance that the equipments used in manufacturing are free of the unwanted impurity, presence of which may alter the safety and efficacy of the drug product. The developed method was based on RP-HPLC leave-taking and quantification of the drug on C-18 column using a mobile phase at flow rate of 1 ml/ min. Quantitation was attained with PDA detector at 200-400 nm based on peak area with linear calibration curves at concentration ranges 5-25 μg/ml for the drug. The method as per ICH guidelines was validated for specificity, linearity, detection limit, quantitation limit, precision, accuracy, robustness, solution stability, and can be effectively used for routine analysis.
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