Abstract: Apixaban is an Anti-coagulant which prevents or reduces the coagulation of blood manifested by prolonging the clotting time. In the present study, a rapid, sensitive and economical UPLC method was developed and fully validated for analysis of Apixaban and its impurities (MPD4, APIX1B, N-Formyl and Methyl ester) in pharmaceutical finished product. Challenging task of separation of highly polar and non-polar impurities simultaneously with good resolution by development of accurate and sensitive UPLC method. The final UPLC method was developed by using Fortis Speed Core C18 column (150 mm × 4.6 mm, 2.6 µm). The temperature of column compartment was maintained at 40 oC. A gradient elution at a flow rate of 0.5 mL/min was employed and detection was carried out at 235 nm. Injection volume of 3 µL was employed. Eluent A : Mixture of 10 mM potassium dihydrogen phosphate, pH adjusted to 5.0 and Methanol in the ratio (90:10 v/v respectively) and eluent B : mixture of 10 mM Potassium dihydrogen phosphate, pH adjusted to 5.0, Acetonitrile, Methanol in the ratio (20:20:60 v/v/v). The validation parameters were inaccordance with FDA and ICH specifications, showing accuracy, precision, specificity, robustness and linearity from 0.1 – 2.5 µg/mL for the Apixaban and its impurities. The limit of detection and limit of Quantitation were Acid impurity and MPD4 impurity (LOD: 0.002%, LOQ: 0.007%), APIX1B impurity (LOD: 0.003%, LOQ: 0.009%), Apixaban (LOD: 0.002%, LOQ: 0.005%), N-formyl impurity (LOD: 0.001%, LOQ: 0.003%), Methyl ester impurity (LOD: 0.001%, LOQ: 0.002%) respectively. The validated method is simple, rapid, linear, precise, robust and method is suitable for Quality control applications.
Keywords: UPLC method, Apixaban Tablets, Atrial fibrillation.
Title: Development and Validation of Stability Indicating UPLC Method for Determination of Related Impurities of Apixaban Tablets
Author: Aakisetti Siva Sankar, G. Srinivas Rao
International Journal of Healthcare Sciences
ISSN 2348-5728 (Online)
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