Original Article

Comparative UV-Spectroscopy and HPLC Methods for Content Analysis of Zolpidem Tartrate in Solid Dosage Forms

  • V. Sampath SARAVANAN
  • Ramadoss REVATHI

Received Date: 14.03.2013 Accepted Date: 04.07.2013 Turk J Pharm Sci 2014;11(2):127-136

A lıigh perfonnance liquid chromatography (HPLC) and ultra-violet spectroscopic (UV) methods were developed and validated for the quantitative estimation of Zolpidem tartrate in solid dosage forms. HPLC method was carried out using reverse plıase technique on RP-18 column with a mobile plıase composed of ammonium acetate buffer pH 5.0 and methanol (30:70, v/v) at ambient temperature. The mobile plıase was pumped at a flow rate of 0.5 ınL/min and detection was made at 243 mn with UV detector. UV method was perfonned with X max at 243 mn with apparent molar absorptivity of 1279.25 L/mol.cm. Both the methods showed good linearity, recovery and precision. No spectra or chromatographic interferences from the tablet excipients were found in UV and HPLC methods. The results of analysis were validated according to ICH guidelines. Statistical comparison was done by studenf s t-test and F-test, which showed no signifıcant difference between the results of both methods. So the proposed methods could be applicable for routine analysis of Zolpidem tartarate in bulk and plıannaceutical formulation.

Keywords: Zolpidem tartrate, Validation. Comparative studies, Studenf s t-test and F-test