Abstract

STABILITY INDICATING RP – HPLC METHOD FOR DETERMINATION OF GEMFIBROZIL IN PHARMACEUTICAL FORMULATION

Sapana U. Ingle*, P. P. Patil , S. D. Barhate and A.R.Umarkar

Abstract

Purpose: To Develop A simple, rapid and accurate and stability indicating RP-HPLC Method for the determination of Gemfibrozil in pure and tablet form. Method: Stability indicating RP-HPLC method. Result: The method showed a linear response for concentrations in the range of 10-50μg/ml using Methanol: Water solution in the ratio (90:10) as the mobile phase with detection at 274 nm and a flow rate of 0.7 ml/min and retention time 2.287min. The value of correlation coefficient, slope and intercept were, 0.999, 12.389and-3.839, respectively. The method was validated for precision, recovery, ruggedness and robustness. The drug undergoes degradation under acidic, basic, peroxide and thermal degradation conditions. All the peaks of degraded product were resolved from the active Pharmaceutical ingredient with significantly different retention time. Conclusion: As the method could effectively separate the drug from its degradation product, it can be employed as a stability indicating one.

Keywords: Gemfibrozil, RP-HPLC, Degradation studies.