Stability-indicating HPLC method for determination of zolpidem in pharmaceutical dosage form

The objective of the method was to develop a simple, precise, rapid and stability indicating high performance liquid chromatographic method (HPLC) for the quantitative determination of a short acting hypnotic drug zolpidem in its formulations. In this method Hypersil-100 ODS-3 column (Thermo Scientific, Waltham, USA) [C18 (5 µ), 25 cm X 4.6 mm, i.d)] was used at ambient temperature using mobile phase consisting of acetonitrile: 30mM phosphate buffer (60: 40 v/v) pH adjusted to 3.5 ± 0.02 with ortho phosphoric acid gave a symmetrical, sharp peak at (tR= 7.02 ± 0.05 min). The detection wavelength was 242 nm and the flow rate 1 mL min-1.In the range of 1 - 6 µg mL-1 the linearity of zolpidem showed a regression coefficient of 0.999. The proposed method was sufficiently selective to distinguish the parent drug and the degradation products after hydrolytic, oxidative, dry heat, wet heat, neutral and photochemical degradation products and from excipients. This developed method was validated by determining its sensitivity, accuracy and precision. The developed method was simple, fast, accurate, precise which separates the drug from its degradants and hence could be applied as a stability indicating method for routine quality control analysis of zolpidem in dosage forms.

Author(s): Deepali A. Bansode and Sunil R. Dhaneshwar

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