Abstract
DEVELOPMENT AND VALIDATION BY ANALYTICAL METHOD RP-HPLC FOR APIXABAN IN TABLET DOSAGE FORM

Manjusha U. Kakde*, Vijayalaxmi A. Chavan and Snehal S. Manekar

ABSTRACT

For the Apixaban, a new, simple, sensitive, and inexpensive RP-HPLC analytical method has been developed in the current investigation. Due to the short analytical run time, the developed and validated RP-HPLC technique was shown to be more cost-effective. The mobile phase of Methanol: Water with 0.15% orthophosphoric acid (OPA) produced the best results. The peaks were suitably clear and symmetric. When evaluated spectrophotometrically, apixaban was shown to exhibit significant absorbance at 277 nm; hence, this wavelength was chosen as the detecting wavelength. The retention time was 4.9 minutes. By injecting 100g/ml of the standard concentration of apixaban, the System suitability was evaluated. The acceptable level of RT, peak area, tailing factor, and theoretical plate were verified. The developed method was validated using Q2 R1 of the ICH guidelines, and parameters like linearity, precision, accuracy, robustness, the limit of detection (LOD), and the limit of quantitation (LOQ) were validated. LOD and LOQ were determined to be respectively 1.3852 ug/ml and 4.202 ug/ml. As a result, quality control laboratories can use the established RP-HPLC method for the regular examination of apixaban in bulk and pharmaceutical dosage forms.

Keywords: Reverse phase-high-performance liquid chromatography, Validation, Apixaban, Thrombosis.


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