Simultaneous Estimation of Acetylsalicylic Acid and Clopidogrel Bisulfate in Pure Powder and Tablet Formulations by High-Performance Column Liquid Chromatography and High-Performance Thin-Layer Chromatography

• Published in: Journal of AOAC International 2008-07, Vol.91 (4), p.750-755
• Main Authors: PATEL, Rashmin B, SHANKAR, Madhira B, PATEL, Mrunali R, BHATT, Kashyap K
• Format: Article
• Language: English
• Subjects: Aspirin; Aspirin - analysis; Biological and medical sciences; Calibration; Chemistry, Pharmaceutical; Chromatography, High Pressure Liquid; Chromatography, Thin Layer; Clopidogrel; Drugs; Food industries; Fundamental and applied biological sciences. Psychology; High performance liquid chromatography; Identification and classification; Indicators and Reagents; Measurement; Methods; Platelet Aggregation Inhibitors - analysis; Powders; Product/Service Evaluations; Reference Standards; Regression Analysis; Reproducibility of Results; Tablets; Thin layer chromatography; Ticlopidine - analogs & derivatives; Ticlopidine - analysis
• ISSN: 1060-3271; 1944-7922
• DOI: 10.1093/jaoac/91.4.750

This paper describes validated high-performance column liquid chromatographic (HPLC) and high-performance thin-layer chromatographic (HPTLC) methods for simultaneous estimation of acetylsalicylic acid (ASA) and clopidogrel bisulfate (CLP) in pure powder and formulations. The HPLC separation was achieved on a Nucleosil C8 column (150 mm length x 4.6 mm id, 5 microm particle size) using acetonitrile-phosphate buffer, pH 3.0 (55 + 45, v/v) mobile phase at a flow rate of 1.0 mL/min at ambient temperature. The HPTLC separation was achieved on an aluminum-backed layer of silica gel 60F254 using ethyl acetate-methanol-toluene-glacial acetic acid (5.0 + 1.0 + 4.0 + 0.1, v/v/v/v) mobile phase. Quantitation was achieved with UV detection at 235 nm over the concentration range 4-24 microg/mL for both drugs, with mean recoveries of 99.98 +/- 0.28 and 100.16 +/- 0.66% for ASA and CLP, respectively, using the HPLC method. Quantitation was achieved with UV detection at 235 nm over the concentration range of 400-1400 ng/spot for both drugs, with mean recoveries of 99.93 +/- 0.55 and 100.21 +/- 0.83% for ASA and CLP, respectively, using the HPTLC method. These methods are simple, precise, and sensitive, and they are applicable for the simultaneous determination of ASA and CLP in pure powder and formulations.