Development and Validation of New RP-HPLC Method for the Determination of Zolpidem Tartrate in Pure and Pharmaceutical Formulations
Journal Title: Scholars Academic Journal of Pharmacy - Year 2013, Vol 2, Issue 5
Abstract
The present work is concerned with application of simple, precise, accurate, reproducible and specific RP-HPLC method for estimation of Zolpidem Tartrate (ZPT) in bulk and pharmaceutical formulations. Separation of ZPT was successfully achieved on a Symmetry XTerra C18 (4.6 x 150mm, 5 m) Waters or equivalent in an isocratic mode utilizing Ammonium Acetate Buffer (4.5 pH): Methanol (40:60%v/v) at a flow rate of 0.8 mL/min and eluate was monitored at 300 nm, with a retention time of 3.14 minutes. The method was validated and the response was found to be linear in the drug concentration range of 20 µg/mL to 60 µg/mL. The values of the slope, intercept and the correlation coefficient were found to be 47336, 13206 and 0.999 respectively. The RSD values for system precision and method precision were found to be 0.14 % (Intra-day), 0.18% (Inter-day) and 0.46 % (Intra-day), 0.14 % (Inter-day) respectively. Accuracy of method was determined through recovery studies which were found to be 98.90-100.87%. Keywords: Zolpidem Tartrate(ZPT), RP-HPLC, Acetate Buffer (4.5 pH), Methanol.
Authors and Affiliations
M. Kiran, S. Ushasri, Srinadth Nissankarao
Keywords
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