alexa Stability-indicating HPLC method for quantification of celecoxib and diacerein along with its impurities in capsule dosage form.
Pharmaceutical Sciences

Pharmaceutical Sciences

Pharmaceutica Analytica Acta

Author(s): Bapatu HR, Maram RK, Murthy RS

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Abstract A novel stability-indicating reverse phase high performance liquid chromatography method was developed and validated for the simultaneous determination of Celecoxib (CEL) and Diacerein (DIN) and its impurities in capsule dosage form. The method was developed using L1 column with gradient using the mobile phase consist of Solution A (pH = 2.3 buffer) and Solution B (methanol and acetonitrile; 50 : 50, v/v). The eluted compounds were monitored at 255 nm. CEL and DIN were subjected to oxidative, acid, base, hydrolytic, thermal and photolytic stress conditions. The developed method was validated as per International Conference on Harmonisation guidelines with respect to specificity, linearity, limit of detection, limit of quantitation, accuracy, precision and robustness. The limit of quantitation results were ranged from 0.07 to 0.09 µg/mL for CEL impurities and 0.052 to 0.065 µg/mL for DIN impurities. This method is suitable for the estimation of impurities and assay of CEL and DIN in capsules dosage forms. © The Author [2014]. Published by Oxford University Press. All rights reserved. For Permissions, please email: [email protected] This article was published in J Chromatogr Sci and referenced in Pharmaceutica Analytica Acta

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