Development and validation of stability indicating thin‐layer chromatography methods for simultaneous estimation of Bisoprolol Fumarate and Hydrochlorothiazide

Abstract

AbstractFor the simultaneous estimation of Bisoprolol Fumarate and Hydrochlorothiazide in combined pharmaceutical dosage form, a simple, selective, rapid, and precise stability indicating high‐performance thin‐layer chromatography method has been developed and validated.The proposed high‐performance thin‐layer chromatography technique includes the usage of high‐performance thin‐layer chromatography plates (Merck) pre‐coated with silica gel 60F254 on aluminum sheets and a cellular segment comprising of methanol:acetonitrile (8:2, v/v). The densiometric measurement of both drugs was performed in the absorbance mode at 223 nm. The method has been used to accurately estimate Bisoprolol Fumarate and Hydrochlorothiazide in a combined tablet dosage form. Both the drugs had been subjected to acid‐alkali hydrolysis, photolytic, thermal, and oxidation degradation and each of them had been discovered to be prone to acid‐alkali hydrolysis, photolytic, thermal, and oxidation degradation. The developed stability‐indicating analytical method was validated. The various validation parameters checked are linearity, inter‐day and intra‐day precision, robustness, accuracy, and so forth.The degradation products obtained were well resolved from the pure drugs with significantly different Rf values. The method can be utilized for stability‐indicating analysis since it successfully separates the drug from its degradation products. The method was successfully validated and validation results are within the acceptable range of International Council for Harmonization guidelines.