Abstract
Objective:- The objective of the present investigation has been to develop simple, accurate and economical RP-HPLC method for quantitation of zolpidem tartrate and its application to its dosage forms(tablets ,capsules). Method:-Chromatographic separation was achieved isocratically using C18 column (hypersil ODS, 250 x 4.6 mm, 5 μm) using a mobile phase, 40:60 (phosphate buffer: acetonitrile). The flow rate was 1 ml/min and effluent was detected at 244 nm and 20μl of sample was injected. The run time was found to be 6 min. Results:- Linearity was observed in the concentration range of 50-150 % for zolpidem tartrate. Percent recoveries obtained for the drugs were 98.99%. The percentage RSD for precision of the method was found to be less than2%. The method was linear over the concentration range for Zolpidem tartarate 50-150 μg/ml. The recoveries of Zolpidem tartarate tablets and capsule were found to be 99.84% and 99.95% respectively hence the developed method is usefull for the estimation of Zolpidem tartarate present in tablet as well as capsule dosage forms. The validation of method was carried out utilizing ICH-guidelines. The described HPLC method was successfully employed for the analysis of pharmaceutical formulations containing combined dosage forms. Conclusion:- From the above experimental results and parameters it was concluded that, this newly developed method for the estimation of Zolpidem tartrate was found tobe simple, precise, accurate and high resolution and shorter retention time makes this method more acceptable and cost effective and it can be effectively applied for routine analysis in research institutions, quality control department in industries, approved testing laboratories, bio-pharmaceutical and bio-equivalence studies and in clinical pharmacokinetic studies in near future.
