DEVELOPMENT AND VALIDATION OF A STABILITY INDICATING RP-HPLC METHOD OF APIXABAN IN COMMERCIAL DOSAGE FORM

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 (R) 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 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.