Forced Oxidative degradation study of Zolpidem tartrate by HPLC

Abstract

A forced oxidative degradation study was successfully carried out and a stability-indicating assay method developed for the determination of zolpidem in the presence of its degradation products. Zolpidem was refluxed with 6% peroxide at 60°C for 48 hrs with constant stirring. The method was developed and optimized by analyzing the forcefully degraded sample. Successful separation of drug from synthetic impurities and degradation products formed under stress condition was achieved on a C₁₈ column (waters Spherisorb 250 mm length×4.6 mm internal diameter and 5 μm particle size) using a mixture of acetonitrile:methanol:water (500:400:100, v/v/v) as mobile phase. Validation of the developed HPLC method was done with respect to linearity, accuracy, precision, specificity and ruggedness. To our knowledge, a rapid stability indicating LC method with oxidative degradation of zolpidem tartrate has not previously reported.

Keywords: Forced degradation, Stability-indicating assay, Oxidation, Zolpidem tartrate, Validation

Journal of Pharmaceutical and Allied Sciences, Vol. 9 No. 2 (2012)