Development and validation of stability indicating UPLC method for the quantitative determination of related substances in moxifloxacin hydrochloride

The present paper describes the development of a simple, economic and time efficient stability indicating UPLC method for Moxifloxacin HCl 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 moxifloxacin 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 Acquity UPLC BEH C18 column using a mixture of potassium di hydrogen phosphate buffer and methanol (80:20, v/v) as mobile phase in a gradient elution mode. The eluents were monitored at 240 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 moxifloxacin HCl.