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Abstract

A simple and precise accurate reverse phase high performance liquid method was developed for the determination of Apixabanin bulk and its dosage form. Chromatographic separation was performed oncolumn, C18(150x4.6 ID) 5µm column with a mobile phase contain the gradient mixture of the solvent (water: Acetonitrile) in the ratio of 55:45(v/v) as mobile phase at the flow rate 1.0 ml/minThe retention time of Apixaban was found to be 4.960 and theoretical plate count for Apixaban was 4207. The percentage of accuracy was found to be 98.40%. As per ICH guidelines the method was validated for linearity, accuracy, precision, limit of detection and limit of quantification, robustness and ruggedness. Linearity of Apixaban was found in the range of 50-150µg/ml. correlation coefficient was 0.994. The LOD and LOQ values for Apixaban were 44.18 and 58.12µg/ml respectively. This demonstrates that the developed method is simple, precise, rapid, selective, accurate and reproducible for estimation of Apixaban in bulk and its dosage form.

Keywords

Apixaban RP-HPLC Method development Validation

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