Stability indicating RP-HPLC method development and validation for determination of 9 impurities in apixaban tablet dosage forms. Robustness study by Quality by Design approach.

Stability indicating RP-HPLC method development and validation for determination of 9 impurities in apixaban tablet dosage forms. Robustness study by Quality by Design approach. Biomed Chromatogr. 2019 Oct 21;:e4719 Authors: V B, Katari NK, Dongala T, Jonnalagadda SB Abstract Quality by Design (QbD) based high-resolution HPLC method is described for 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 (ACN) 10:90 v/v. The Gradient program was at 0 min, MP-A 75%, B 25%; 20 min, MP-A 65%, B 35%; 30 min, MP-A 40%, B 60%; 40 min, 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 by using Zorbax RX C18 250 x 4.6 mm column, 5μm (1.0 mL/min, 280 nm, 50 μL) and column temperature 40°C. Several separation studies were carried out using Design of Experiments (DoE) 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. PMID: 31634417 [PubMed - as supplied by publisher]
Source: Biomedical Chromatography : BMC - Category: Biomedical Science Authors: Tags: Biomed Chromatogr Source Type: research