Optimization and Validation of Rp-Hplc Stability Indicating Method for Determination of Olmesartan Medoxomil and Its Degraded Product

作者: Purnima D. Hamrapurkar , Kamalesh K. Gadapayale

DOI: 10.6703/IJASE.2013.11(2).137

关键词:

摘要: Stability testing of an active substance or finished product provide evidence as to the quality that it remains acceptable up stated period under storage condition on label. With this objective a stability indicating high performance liquid chromatographic method has been established for analysis Olmesartan medoxomil in presence degradation products. The drug was subjected stress hydrolysis, oxidation, photolysis, thermal degradation. Extensive found acid medium and alkaline medium. Minimum while there no photolytic condition. Successful separation from formed achieved C18 column using methanol: water (60:40, v/v), pH 3.75 adjusted with 10mM o-phosphoric mobile phase. Flow rate 1 ml min^(-1) detector set at wavelength 270 nm. validated linearity, range, precision, accuracy, limit quantification detection. Because effectively separates their products, can be used method.

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