ISSN : 2348 - 8948

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Volume : 6 Issue :4 Month : April (2018)
Page Numbers : 464-474

Development And Validation Of Stability Indicating Hplc Method For Estimation Of Leuprolide Acetate In Its Parenteral Dosage Form

Foram Vandara*, Chirag. J. Patel, Nikita A. Patel, M. M. Patel
In this study, A sensitive, accurate and cost effective RP-HPLC method was developed using YMC-Pack ODS-A(150mmX46mm), 3 stationary phase for quantitative determination of leuprolide acetate in its 3 month depot formulation. Chromatographic separation was achieved by using Mobile Phase A [Buffer (Triethylamine in milli Q water): Organic mixture (Acetonitrile: n-Propanol)(60:40)] and Mobile phase B (Buffer : Organic mixture)(50 : 50) by Gradient method under UV detection at 220 nm. Retention time was found to be 12 to 15 min. This drug was subjected to stress conditions like Acid, Alkali, Thermal, Photolytic and Humidity Degradation. Linearity was found to be in the range of 80-150 microgram/ml. The accuracy of present method was evaluated at 50%, 100% and 150%. The method was found to be robust. The method enables high throughput and is easy to perform.
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