A rapid HPLC method for determination of zolpidem and its degradation product in tablets using a monolithic column.

ABSTRACT

A simple, accurate reverse phase high-performance liquid chromatographic method, utilizing a monolithic silica column, for determination of zolpidem hemitartrate and its degradation product in tablet dosage form was developed. Analysis was achieved on the monolithic, C18 (100 mm, 3.9 mm) column, in isocratic mode with acetonitrile-NaH2PO4 (pH 7.0; 0.01 M; 3565, v/v) as mobile phase and a flow rate of 2.5 mL/min at room temperature with UV detection at 245 nm. Diazepam was applied as an internal standard. The retention time of zolpidem and its degradation product was 2.14 and 1.89, respectively. Calibration curve was linear in the range of 0.12-5 µg/mL and the recovery values were found to be 97-101%. The limit of quantitation was determined 0.12 µg/mL. The relative standard deviation values of intraday and interday studies were calculated as 0.13-1.1% and 0.54-1.3%, respectively.