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
- 1 Department of Process Research and Development, Megafine Pharma (P) Ltd., Nashik, India
- 2 Department of Process Research and Development, Megafine Pharma (P) Ltd., Nashik, India
- 3 Department of Process Research and Development, Megafine Pharma (P) Ltd., Nashik, India
- 4 Department of Process Research and Development, Megafine Pharma (P) Ltd., Nashik, India
- 5 Department of Chemistry, Deogiri College, Aurangabad, India
- 6 Department of Process Research and Development, Megafine Pharma (P) Ltd., Nashik, India
Abstract
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<sup>®</sup> C18 (4.6 mm × 100 mm, 2.7 μ) 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°C 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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