Development and Validation of Analytical Methods for the Quantitation of Some Drugs in Bulk and In Pharmaceutical Dosage Form

Abstract

Simple, specific, precise, accurate, robust, and novel user friendly reverse phase - high performance liquid chromatographic methods were developed with stability indicating attributes for simultaneous estimation of Metoprolol Succinate and Chlorthalidone (Method I), Bisoprolol Fumarate and Amlodipine Besylate (Method II), , Clopidogrel Bisulphate and Atorvastatin Calcium (Method III), Telmisartan and Rosuvastatin Calcium (Method IV), Chlorthalidone and Amlodipine Besylate (Method V); and for estimation of Cilnidipine (Method VI) and Sitagliptin Phosphate Monohydrate (Method VII) individually in bulk and in pharmaceutical dosage form with minimized drug extraction steps. The chromatographic analysis was performed isocratically using a C18 column(s) as stationary phase maintained at ambient temperature (about 25°C) and the detection was carried out by using a UV detector. The peaks for degraded product(s) generated during forced degradation study were well resolved from the active analyte(s) peak shows that the proposed methods are specific and stability indicating. The forced degradation study was performed on individual drug substance(s) as well as their drug product by subjecting them to acid, alkali, oxidative, thermal, photolytic, and humidity stress conditions. The developed methods were validated with respect to specificity, linearity, detection limit, quantitation limit, accuracy, precision, robustness, and solution stability as per International Conference on Harmonization Q2 (R1) guidelines and can be used successfully for regular analysis. newline