Validated Column High-Performance Liquid Chromatographic Method for Determination of Aspirin and Clopidogrel in Combined Tablets in the Presence of Degradation Products Formed Under ICHRecommended Stress Conditions

• Published in: Journal of AOAC International 2009-01, Vol.92 (1), p.152-157
• Main Authors: Kachhadia, Pankaj K, Doshi, Ashish S, Joshi, Hitendra S
• Format: Article
• Language: English
• ISSN: 1060-3271; 1944-7922
• DOI: 10.1093/jaoac/92.1.152

The development and validation of a column high-performance liquid chromatographic assay method for the determination of aspirin and clopidogrel in tablet formulation are described. The combination formulation was subjected to International Conference on Harmonization-recommended stress conditions. Separation of the drugs from the degradation products formed under stress conditions was achieved on an octasilyl (C8) column using 0.3 orthophosphoric acidacetonitrile (65 + 35, v/v) mobile phase. The method was validated for specificity, linearity, limits of detection and quantification, precision, accuracy, and robustness. The method was found to be specific against placebo interference and during the forced degradation. The response was linear in the concentration range of 30.0120.0 g/mL for aspirin and 15.060.0 g/mL for clopidogrel, with a correlation coefficient of 0.9999 for both. The relative standard deviation values for intra- and interday precision were