Method development and Validation for simultaneous estimation of Melatonin and Zolpidem tartrate by using RP-HPLC
Journal Title: Scholars Academic Journal of Pharmacy - Year 2015, Vol 4, Issue 4
Abstract
A simple, accurate, economic, sensitive, rapid and robust reverse phase high performance liquid chromatography (RP-HPLC) method was developed for the estimation of melatonin and Zolpidem tartrate in pure and tablet dosage forms. Hypersil C18 ODS column (250x4.6mm,5µ) was used with a mobile phase containing a mixture of phosphate buffer and acetonitrile in the ratio of 55:45% v/v. The flow rate was maintained at 1.0 ml/min. Results were determined at 265 nm with a fixed wave length PDA detector. The linearity for melatonin was found between 6-42 µg/ml and between 10-70 µg/ml for zolpidem tartrate. The retention times were found as 2.517 and 3.630 for melatonin and zolpidem tartrate respectively. Validation parameters like accuracy, precision, robustness, LOD and LOQ, assay, system suitability parameters and stability studies were determined and examined by applying validated parameters. Keywords: Zolpidem tartrate, Melatonin, RP-HPLC, Method development, Validation.
Authors and Affiliations
Ganesh Akula, Yadagiri Talari, S. S. Phanindra, Dr. A. Jaswanth
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