DEVELOPMENT AND VALIDATION OF A STABILITY INDICATING RP-HPLC METHOD OF APIXABAN IN COMMERCIAL DOSAGE FORMAbstract
The aim of this study is to develop a sensitive, specific, rapid, and precise reverse-phase high-performance liquid chromatography (RP-HPLC) method and validate it for the quantification of process-related and degradation impurities of apixaban; an anticoagulant drug. The chromatographic separation was achieved on a Sigma-Aldrich’s Ascentis Express® 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 the photodiode array detector was set at 225 nm. The newly developed method was utilized to detect nine process-related impurities (Imp-1 to Imp-9) in a test sample of Apixaban. 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 guidelines and found to be specific, precise, sensitive, and robust. In conclusion, the RP-HPLC method was successfully developed and validated then effectively applied to analyze both; Apixaban drug substance and product.
I. Al-Ani, M. Hamad, R. Al-Shdefat, K. Mansoor, F. Gligor and W. A. Dayyih *
Department of Pharmaceutical Medicinal Chemistry and Pharmacognosy, Faculty of Pharmacy & Medical Sciences, University of Petra, Amman - Jordan.
29 December 2019
05 April 2020
10 October 2020
01 January 2021