ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF APIXABAN BY RP-HPLC
Journal: Indian Drugs (Vol.54, No. 4)Publication Date: 2017-04-29
Authors : Kashid A. M.; Vidhate M. B.; Ingale M. R.;
Page : 76-79
Keywords : ;
Abstract
A simple, fast and precise high performance liquid chromatographic method is developed and validated for apixaban as per ICH guideline. Chromatographic separation of drugs was performed on a Kromasil C18 column (250 mm x 4.6 mm, 5 μ) with a mobile phase comprising of sodium acetate: acetonitrile in the ratio 50:50 (V/V) at a flow rate of 1 mL/min. The described method was linear over a concentration range of 10-50μg/mL (r2> 0.994) for apixaban. The limit of detection (LOD) was found to be 0.36μg/mL, whereas the limit of quantification (LOQ) was found to be 1.09μg/mL. The recovery was calculated by the standard addition method. The average recovery was found to be 96.87 %. Developed method was found to be simple, accurate, precise and rapid, hence it can be used for quality control of apixaban.
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