METHOD DEVELOPMENT AND VALIDATION OF GLIBENCLAMIDE IN TABLET DOSAGE FORM BY USING RP-HPLC
Abstract
Author(s): Koteshwara K B, Naha Anup, Sunil P, Sai Kiran
A simple, precise, reliable, rapid and reproducible reversed phase–high-performance liquid chromatography method was developed and validated for the estimation of glibenclamide. Chromatographic separation was achieved isocratically with Grace Vydac C18 column (250 × 4.6 mm, 5µ) and Acetonitrile:20 mM ammonium acetate buffer, pH 4.5 (50:50) as mobile phase, at a flow rate of 1 ml/min. Detection was carried out at 300 nm. Parameters such as linearity, precision, accuracy, robustness recovery are studied as per ICH guidelines. The retention time for Glibenclamide was found to be 15 min. Linearity for glibenclamidewas in the range of10–70 µg/ml and mean recoveries obtained for glibenclamide was99.22±1.07% and relative standard deviation (RSD) was0.90. The correlation coefficients for all components were close to 1. Developed method was found to be accurate, precise, selective and rapid for estimation of glibenclamide.
