Development and Validation of Stability Indicating RP-HPLC Method on Core Shell Column for Determination of Degradation and Process Related Impurities of Apixaban—An Anticoagulant Drug

A rapid, specific, sensitive, and precise reverse-phase HPLC method for the quantitative determination of process related and degradation impurities of Apixaban, an anticoagulant drug is described. The developed RP-HPLC method was successfully applied to the analysis of both Apixaban drug substance...

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Published inAmerican journal of analytical chemistry Vol. 6; no. 6; pp. 539 - 550
Main Authors Landge, Shashikant B., Jadhav, Sanjay A., Dahale, Sunil B., Solanki, Pavankumar V., Bembalkar, Saroj R., Mathad, Vijayavitthal T.
Format Journal Article
LanguageEnglish
Published 01.05.2015
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Summary:A rapid, specific, sensitive, and precise reverse-phase HPLC method for the quantitative determination of process related and degradation impurities of Apixaban, an anticoagulant drug is described. The developed RP-HPLC method was successfully applied to the analysis of both Apixaban drug substance and drug product. The chromatographic separation was achieved on a Sigma-Aldrich's Ascentis Express C18 (4.6 mm x 100 mm, 2.7 mu ) HPLC column with a runtime of 40 min. Mobile phase-A and mobile phase-B were phosphate buffer and acetonitrile respectively. The column oven temperature was set at 35 degrees Celsius and photodiode array detector was set at 225 nm. Nine process related impurities (Imp-1 to Imp-9) have been detected in test sample of Apixaban, by using newly developed RP-HPLC method. Forced degradation study was carried out under acidic, alkaline, oxidative, photolytic and thermal conditions to demonstrate the stability-indicating nature of the developed RP-HPLC method. The developed method was validated as per ICH guideline, and found to be specific, precise, sensitive and robust.
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ISSN:2156-8251
2156-8278
DOI:10.4236/ajac.2015.66052