STUDIES IN DEVELOPMENT, VALIDATION AND APPLICATION OF ANALYTICAL RP-HPLC METHOD FOR QUANTITATIVE ESTIMATION OF GLIPIZIDE FROM ITS BULK AND FORMULATION

Abstract

A RP-HPLC method has been developed for the estimation of glipizide (GLP). The proposed method is based on the separation of the drug in reversed-phase mode using BDS HYPERSIL C18 (4.6 mmø×250 mm) analytical column, mobile phase methanol:water 70:30 V/V, at the flow rate of 1.0 mL min-1 and detection wavelength 222 nm. GLP was well resolved and retained at t = 3.86 minutes. This RP-HPLC method was validated as per the recommendations of ICH Revised Q2(R1) guidelines of analytical method validation, in order to prove that the new analytical method meets the reliability characteristics. The method characteristics showed the capacity of an analytical method to keep, all over the time, the basic standards for validation: selectivity, linearity, precision, accuracy and sensitivity. The method was found linear over the range 1-7 µg mL-1. The LOD and LOQ were 0.5281 and 1.761 µg mL-1 for GLP. The validated method was successfully used for quantitative estimation(assay) of GLP from in-house formulation and marketed formulations.