Validated Stability Indicating HPLC Method for Determination of Zolpidem in the Presence of Its Degradation Products

Zolpidem is a hypnotic agent used for the treatment of insomnia. In this study a stability indicating HPLC method was developed for the determination of zolpidem in the presence of its degradation products. Stress degradation of zolpidem was performed under acidic, alkaline, oxidative, heat and photolytic conditions. Separation of zolpidem and its degradation products were performed on a Nova-Pak CN column using KH2PO4 30 mM and acetonitrile (65: 35, v/v at pH 6) as mobile phase. Acceptable linearity (r 2 >0.999) and precision (CV value <1.5%) were achieved over the concen- tration range of 1-20 g/mL. Degradation of zolpidem was observed under acidic, alkaline, oxidative conditions and also exposure to UV light. The proposed method was used for assay determination of zolpidem tablets with no interfering from excipients.