Development and Validation of UV Spectrophotometric Method for Detection of Glibenclamide during Dissolution in Alkaline Borate Buffer pH 9.5

This article describes the development of UV spectrophotometric method for detection of glibenclamide during its dissolution in alkaline borate buffer pH 9.5 because no official UV spectrophotometric method is described for this drug and no such method has been developed for estimating the drug in this medium. A stock solution of 20 g/ml was prepared. Various aliquots of the stock solution were transferred to a series of 10 ml capacity volumetric flasks so as to prepare various dilutions between the ranges of 2-12 g/ml. To each dilution 0.1 ml of concentrated hydrochloric acid was added and a calibration curve was formed at 229.5 nm between absorbance on Y- axis and concentration on X- axis. The linearity range was found to be between 2.0 to 12.0 g/ml. The limit of detection (LOD) and limit of quantification (LOQ) were found to be 0.23 g/ml and 0.71 g/ml respectively. The repeatability, interday and intraday precision (measured in terms of percent relative standard deviation, %RSD) was always less than 0.94%. The accuracy of the developed method were measured by recovery studies and was found to be between 100.39%±1.03% and 102.94%±1.46%. Thus, the developed method is specific, accurate and precise as validated according to recommendations by ICH guidelines.