Development and validation of simple, precise UV spectrophotometric methods for the quantification of Mebeverine HCl in API and Marketed Products

Abstract

Simple, rapid, economic and sensitive UV spectrophotometric methods using three solvent mediums viz., 0.1N HCl, Phosphate buffer pH 6.8 and Phosphate buffer pH 7.4 were developed and validated for the estimation of Mebeverine HCl in active pharmaceutical form, Marketed tablets and capsules. The developed methods were validated in terms of linearity, accuracy, precision, and specificity, limit of detection and limit of quantification as per ICH guidelines. The purity of Mebeverine HCl was characterized by melting point and FTIR. At determined absorption maxima of 263 nm for all solvents proved to be linear in the range of 1-50 µg/ml and exhibited good correlation coefficient (R2 = 0.9999, 0.9992, 0.9999) and recovery of (99.00 – 104.55%). This method is applied for two marketed Mebeverine HCl brands and results were in good agreement with label claim. The methods were validated statistically and by recovery studies for linearity, precision, repeatability, and reproducibility. The obtained results proved that the method can be employed for the routine analysis of Mebeverine HCl in active pharmaceutical form as well as in the commercial marketed formulations viz., tablets and capsules.