Related Experiment Video
Updated: Jan 5, 2026

An Intestine/Liver Microphysiological System for Drug Pharmacokinetic and Toxicological Assessment
Published on: December 3, 2020
Stability-indicating RP-HPLC method development and validation for determination of nine impurities in apixaban
Velusamy B Subramanian1, Naresh Kumar Katari1,2, Thirupathi Dongala3
1Department of Chemistry, School of Science, GITAM deemed to be University Hyderabad, Medak, Telangana, India.
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 C18 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.
More Related Videos
07:29HPLC Coupled with Chemical Fingerprinting for Multi-Pattern Recognition for Identifying the Authenticity of Clematidis Armandii Caulis
Published on: November 11, 2022
10:33Development of Inhibitors of Protein-protein Interactions through REPLACE: Application to the Design and Development Non-ATP Competitive CDK Inhibitors
Published on: October 26, 2015
Related Concept Videos
Clinically Relevant Drug Product Specifications: Methods of Establishment
Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence
Drug Dissolution: Requirements and Profile Comparison
In Vitro Drug Release Testing: Overview, Development and Validation
Data Validation
Key parameters for method validation include:
Factors Influencing Drug Absorption: Pharmaceutical Parameters