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

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Original Articles: 2011 Vol: 3 Issue: 1

Development and validation of stability indicating method for the quantitative determination of Raloxifene hydrochloride and its related impurities using UPLC


The present paper describes the development of a simple, economic and time efficient stability indicating UPLC method for Raloxifene hydrochloride (RLH) in the presence of its impurities and degradation products generated from forced degradation studies. The drug substance was subjected to stress conditions of acid hydrolysis, base hydrolysis, oxidative hydrolysis, photolysis and thermal degradation. The degradation of Raloxifene hydrochloride was observed under oxidative hydrolysis and base hydrolysis. The drug was found to be stable in all other stress conditions applied. Successful separation of the drug from synthetic impurities and degradation products formed under forced degradation was achieved on a Extended C18 column using a mixture of 5mM ammonium acetate and methanol (50:50,v/v) as mobile phase in an isocratic elution mode. The eluents were monitored at 280 nm. The developed UPLC method was validated with respect to linearity, accuracy, precision, specificity and robustness. It can be used to test the stability samples of Raloxifene HCl.

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