A quality by design-based high-resolution HPLC method successfully quantified nine known impurities in apixaban tablet dosage forms with good peak resolution.
A new QbD-based RP-HPLC method was developed and validated for the reliable quantification of nine impurities in apixaban tablets.
Abstract A quality by design (QbD) based high‐resolution HPLC method is described for determination of impurities in apixaban (APX) in the tablet dosage form. Employing a simple and stability‐indicating HPLC method, nine known impurities were quantified with good peak resolution. Mobile phase A (MP‐A) was prepared with buffer and acetonitrile 90:10 v/v, while mobile phase B (MP‐B) contained water and acetonitrile 10:90 v/v. The gradient program was 0 min, MP‐A 75%, B 25%; 20 min, MP‐A 65%, B 35%; 30 min, MP‐A 40%, B 60%; 40min, MP‐A 40%, B 60%; 42 min, MP‐A 75%, B 25%; and 50 min, MP‐A 75%, B 25%. The chromatographic separation was achieved using a Zorbax RX C 18 250 × 4.6 mm column, 5 μm (1.0 ml min −1 , 280 nm, 50 μl) and a column temperature of 40°C. Several separation studies were carried out using design of experiments to optimize the method. Validation results confirm the applicability of the developed method for quality analysis and stability studies of the regular product on the manufacturing stream.
Subramanian et al. (2019) studied this question. RP-HPLC method was evaluated on Determination of nine impurities in apixaban tablet dosage forms. A quality by design-based high-resolution HPLC method successfully quantified nine known impurities in apixaban tablet dosage forms with good peak resolution.