UV-VISIBLE SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION OF ASSAY OF BENIDIPINE HYDROCHLORIDE TABLET FORMULATION

Simple, rapid, sensitive, precise and specific UV spectrophotometric method for the determination of Benidipine HCl in bulk drug and pharmaceutical dosage form were developed and validated. In this method solution of Benidipine HCl were prepared in methanol. Benidipine HCl standard solution was scanned in the UV rang (400-200nm) in a 1cm quartz cell in a double beam UV spectrophotometer. The standard solution of Benidipine HCl showed maximum absorption at wavelength 237 nm. The method obeys Beer’s law in the concentration range from 2-10 μg/ml. The correlation coefficient was found to be 0.991 and regression of the curve was found y = 0.0680x +0.031 with excellent recovery 99-104%. Limit of detection and limit of quantitation were found to be 0.222 μg/ml and 0.674μg/ml respectively. The method was validated for several parameters like accuracy, precision as per ICH guidelines. Statistical analysis proved that the methods are reproducible and specific for the estimation of the said drug. These methods can be adopted in routine assay analysis of Benidipine HCl in bulk or tablet dosage form.