Development And Validation Of A Stability Indicating Reverse Phase Hplc-Pda Method For Determination Of Apixaban In Bulk And Pharmaceutical Dosage Form

Abstract

A simple, authentic and stability indicating high performance liquid chromatographic method for determination of Apixaban in bulk and pharmaceutical formulations is develop and validate as per ICH Q2 R1 Guidelines. The separation was performed on Agilent Eclipse Plus C18 column with Acetonitrile and water as mobile phase in gradient mode. A flow rate of 0.7 mL/min with an injection volume of 20 μL was selected for this study and the proposed method was validated with different parameters such as Linearity, Precision, Accuracy, Robustness, Limit of Detection (LOD) and Limit of Quantification (LOQ). The separation was achieved at a temperature of 30ºC and the eluents were observed by photo diode array detector set at 279 nm. A linear range of 1-12 μg/mL with a correlation coefficient of 0.999 unfolds good linear relationship between area and concentration in calibration curve. The retention time obtained was at 3.9 ± 0.05 min. The LOD and LOQ were found to be 0.09 μg/mL and 0.27 μg/mL respectively. A recovery of Apixaban in tablet formulation was observed as 98.89 % ± 0.34. Percentage assay of Apixaban tablets (Eliquis®) was found to be 99.97 % ± 0.63. Stability studies indicate that the drug was stable to oxidation, thermal and photo degradation. The drug gives 3
different degradation products on exposure to acidic condition and 3 degradation products on alkaline condition. The method was applied without any interference from excipients, for determination of drug in coated tablets. It is suggested that the proposed HPLC methods could be used routine quality control and dosage form assay of Apixaban