Journal of Chemical and Pharmaceutical Research (ISSN : 0975-7384)

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Original Articles: 2015 Vol: 7 Issue: 8

Development and validation of stability indicating RP-HPLC method for the determination of pazopanib hydrochloride in bulk drug and its pharmaceutical dosage form

Abstract

A simple, sensitive, reproducible and stability indicating RP-HPLC method for the determination of Pazopanib hydrochloride in bulk and pharmaceutical dosage form has been developed and validated. Chromatography was carried out by isocratic technique on a reversed phase C18 ZORBAX Eclipse Plus column (100 x 4.6 mm x 3.5μ particle size) containing mobile phase of Phosphate buffer PH 2.5 (adjusted with diluted ortho phosphoric acid) and methanol in the ratio of 55:45% v/v at a flow rate of 1.0mL/min. The analyte was monitored using PDA detector at 270nm wave length. The retention time was found to be 3.18 min for Pazopanib hydrochloride. The proposed method was found to be linear in the concentration range of 30-80μg/mL with a regression factor > r2 0.999. The developed method was validated according to ICH Q2B guidelines. Stress condition tests which covered acid, alkali, peroxide, photolytic and thermal degradation was carried and to prove the specificity of the method and the degradation was achieved. Hence this developed method can be applied for the stability indicating RP-HPLC method for the determination of Pazopanib hydrochloride in bulk and pharmaceutical dosage forms and also in routine quality control analysis.