Rapid and Reliable Determination of Glipizide in Pharmaceutical Samples by HPLC and Its Degradation Study

A simple, specific and rapid high-performance liquid chromatographic (HPLC) method for the determination of glipizide (GPZ) in pharmaceutical sample is described. Reversed phase chromatography was performed on an Inertsil ODS 3V (150 × 4.6mm; 5μm particle size) column with an isocratic mobile phase consisting of 10mM potassium dihydrogen phosphate (pH 3.9) and methanol (60:40 v/v). The effluent was monitored on a uv detector at 220nm and the column temperature was maintained at 35°C. Linear response (r=0.9999) was observed over the range, 1-450μgmL-1; and the limits of detection (LOD) and quantification (LOQ) were calculated to be 0.03 and 0.09 μgmL-1, respectively. Both intra-day and inter-day precisions at three tested concentrations were excellent, with %RSD values of <1% and the accuracy was better than 1.5% (RE). The method was also validated for robustness, ruggedness and selectivity and the results were satisfactory. The method was applied to the determination of GPZ in tablets and the results agreed well with the label claim and those obtained by European Pharmacopeial method. Entire assay was complete in less than 10min. As part of degradation study, the drug was subjected to acid-, base-, peroxide-, heat-, and light-induced stress conditions, and the drug was found to be susceptible to degradation under oxidation, and inert to other conditions.