Development and validation of stability indicating method for estimation of buparvaquone by forced degradation studies

Tavneer Kutubuddin, Shaikh and Sushil Suresh, Shelke and Kakde Baliram, Rajendra and Lalatsa, Aikaterini (2020) Development and validation of stability indicating method for estimation of buparvaquone by forced degradation studies. Indian Journal of Pharmaceutical Education and Research, 54 (3). pp. 790-797. ISSN 0019-5464 (https://doi.org/10.5530/ijper.54.3.131)

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Abstract

A simple, rapid, precise and accurate stability indicating high performance liquid chromatographic method was developed for the determination of Buparvaquone in bulk as well as pharmaceutical dosage form by forced degradation studies. Princeton C18 Column (4.6 mm × 150 mm, 5µ) and mobile phase containing 1% Glacial Acetic acid and Acetonitrile in the ratio 5:95 v/v was used throughout the study. The flow rate was 0.9 ml/min and the detecting wavelength was kept as 251 nm using PDA detector. Retention time of Buparvaquone was found to be at 8.6 ± 0.5 min. The method was validated according to ICH Q2(R1) guidelines. The method was found to be linear within concentration range of 2-20 µg/ml with correlation coefficient 0.999 and other parameters are also under permissible limits. Buparvaquone was subjected to various stress conditions like Acidic, Basic, Neutral, Thermal, Peroxide and Photolytic. Amongst all, the drug was found to be more degraded under Basic as well as Peroxide conditions.