TITLE

RP-RRLC method development and validation for determination of Zafirlukast intermediate and it's related substances in the bulk drug

AUTHOR(S)
Lalitha, G.; Kumar, P. K. Seshu; Gowthami, K.; Reddy, T. Karnaker; Mohan, T. Krishna
PUB. DATE
November 2011
SOURCE
Journal of Pharmacy Research;Nov2011, Vol. 4 Issue 11, p4234
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
This present study reports, a simple, specific, accurate and validated stability indicating reverse phase-rapid resolution liquid chromatography for determination of Zafirlukast intermediate and its impurities in the bulk drug. The method employed Hypersil Gold C18 , 2.1 x 100 mm , 1.9 µ column and mobile phase A contains Buffer ( pH-3.0) -- and mobile phase B contains Acetonitrile, Methanol and Water (85:10:05) at flow rate of 0.8 ml/min and UV-detection at 215 nm. No other co-eluting, interfering peak from excipients, impurities, or degradation products due to variable stress conditions was found, and method is specific for the determination of the Zafirlukast in presence of its degradation products. The method was validated in terms of linearity, precision, accuracy, specificity, robustness, and solution stability. As the method could effectively separate the drug from its degradation products, it can be employed as a stability indicating analytical method. Present work also describes the development and validation of Reverse phase rapid resolution liquid chromatography (RP-RRLC) method for the determination of impurities of zafirlukast. The method employed same chromatographic condition as above and validated in terms of linearity, accuracy, precision, LOD, LOQ, and solution stability.
ACCESSION #
74292585

 

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