Analytical method development and validation of glipizide by RP-UPLC method

A simple, precise, accurate method was developed for the estimation of Glipizide by RP-UPLC technique. Chromatographic conditions used are stationary phase BEH C18 (100mm x 2.1mm, 1.8μm). Mobile phase composition of 0.01N KH₂PO₄: acetonitrile in the ratio of 50: 50 and flow rate was maintained at 0.3ml/min, detection wave length was 234nm, column temperature was set to 30°C. System suitability parameters were studied by injecting standard six times and results were well under the acceptance criteria. Linearity study was carried out for 25% to 150% levels and R² value was found to be 0.999. Precision was found to be 0.5 for repeatability and 0.3 for intermediate precision. LOD and LOQ are 0.05μg/ml and 0.14μg/ml respectively. By using above method, assay of marketed formulation was found to be 100.03%. Degradation studies of Glipizide were done in all conditions. Purity threshold was more than purity angle and lies within the acceptable range.