Abstract

DEVELOPMENT AND VALIDATION OF HPTLC METHOD FOR ESTIMATION OF ZOLPIDEM IN PHARMACEUTICAL DOSAGE FORMS

Deepali A. Bansode*, and K.R.Mahadik, Principal

Abstract

Objective: This paper describes a new, simple, precise, accurate and specific HPTLC method for estimation of zolpidem as a bulk drug and in tablet dosage forms. Methods: Chromatographic separation of the drug was performed on aluminum plates pre-coated with silica gel 60 F254 as the stationary phase and a mobile phase comprising of water: methanol: acetic acid (8.0: 2.7: 0.3v/v/v). Densitometric quantification of zolpidem was carried out at 245 nm. Zolpidem was detected satisfactorily with an Rf value 0.42±0.03. Results: The accuracy and reliability of the method was assessed by evaluation of linearity (100- 1000 ng/spot), precision (intra-day RSD 0.52% and inter-day RSD 0.91%), accuracy (99.12-100.10%) and specificity according to ICH guidelines. Conclusion: The proposed HPTLC method is simple, precise, accurate, specific, reproducible and less economic without interference from the excipients. The developed method is suitable for routine analysis of zolpidem in bulk and as a tablet dosage form.

Keywords: Zolpidem, HPTLC, Densitometric estimation, Method development, Validation.