development and validation of RP-HPLC method for determination of glibenclamide in pharmaceutical dosage forms

Abstract

A rapid, linear, precise, selective and accurate reverse phase HPLC method was developed and validated for simultaneous estimation of glibenclamide in tablet dosage form. The method employed for analysis using methanol as a solvent. The wavelength UV 300 nm was selected for estimation and linearity was observed in the concentration range of 160 - 240 μg/ml for glibenclamide respectively. The recovery studies ascertained the accuracy of the proposed method and the results were validated as per ICH guidelines. The method can be employed for estimation of pharmaceutical dosage formulations with no interference from any other excipients and diluents. The resolution between the closest peaks glibenclamide was more than 1.5 gives a linear response (r2>0.999). The method can be used for quality control assay of the bulk and finished dosage form as single component. Moreover, the method was estimated as per ICH guidelines and the results were found to be within the acceptable range. Hence, the proposed method can be used for the routine quality control of the drugs and can also be applied to stability of glibenclamide in pharmacokinetic studies.