Key result
Validated HPLC method for apixaban achieves ~97% average recovery.
Why the study?
A simple, fast, and precise method for estimation of apixaban was needed for quality control as per ICH guidelines.
A simple, accurate, and precise RP-HPLC method was developed and validated for the quality control estimation of apixaban.
Answers are grounded in this paper and cite their sources.
Validated HPLC method for apixaban quantification; extends analytical options for research but leaves open clinical adoption.
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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Kashid et al. (2017) studied this question. RP-HPLC method for apixaban was evaluated on Method validation parameters (linearity, LOD, LOQ, recovery). A high performance liquid chromatographic method was developed and validated for apixaban, demonstrating linearity over 10-50μg/mL and an average recovery of 96.87%.
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