Abstract

Simple, sensitive, rapid and cost effective spectrophotometric methods were developed and validated for simultaneous estimation of Alprazolam (ALP) and Mebeverine hydrochloride (MEB) in Bulk Drug and Pharmaceutical Dosage Form. Developed methods were applied to perform analysis of marketed formulation (MEBASPA-AL) used in anxiety and irritable bowel syndrome. The drugs obeyed the Beer’s law in the concentration range of 2-10µg/ml for ALP and 10-50µg/ml for MEB. In UV-Spectrophotometric methods, estimation of ALP and MEB was carried out at amplitude 220.45 nm and 242.55 nm for First Order Derivative Spectrophotometric Method (method-A); at difference in absorbance between 217 nm and 227 nm and difference in absorbance between 257 nm and 267nm for Dual Wavelength Method (method-B) and 222 nm and 262.40 nm for Simultaneous Equation Method (method-C) using methanol as solvent. The values of limit of detection (LOD) and limit of quantitation (LOQ) were found to be 0.165 μg/ml and 0.498 μg/ml for ALP and 2.26 μg/ml and 6.87 μg/ml for MEB by method-A, 0.241 μg/ml and 0.736 μg/ml for ALP and 0.211 μg/ml and 0.641 μg/ml for MEB by method-B, 0.351 μg/ml and 0.106 μg/ml for ALP and 1.115 μg/ml and 3.37 μg/ml for MEB by method-C respectively. The % assay was found to be 99.40% for APL and 101.36 % for MEB by method-A, and by method-B it was found to be 101.40% for APL and 99.52% for MEB and by method-C it was found to be 99.40% for APL and 98.12% for MEB which within range (99-102%). The precision values were less than 2% R.S.D for all methods. So, all developed methods were validated in terms of linearity, limit of detection, limit of quantification, accuracy, precision, and robustness according to ICH guideline which proved suitability of the developed method for the routine estimation of ALP and MEB in pharmaceutical dosage form.