New High-Performance Liquid Chromatographic Method for Determination of Clopidogrel in Coated Tablets
| Autor: | Martin Steppe, Elfrides Eva Scherman Schapoval, Letícia Lenz Sfair, Juliana Sippel |
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| Rok vydání: | 2008 |
| Předmět: |
Pharmacology
Aqueous solution Chromatography Correlation coefficient Analytical chemistry Linearity Analytical Chemistry chemistry.chemical_compound chemistry Chromatography detector Phase (matter) Ultraviolet light Environmental Chemistry Particle size Agronomy and Crop Science Triethylamine Food Science |
| Zdroj: | Journal of AOAC INTERNATIONAL. 91:67-72 |
| ISSN: | 1944-7922 1060-3271 |
| Popis: | A new high-performance liquid chromatographic method was developed and validated for clopidogrel determination in pharmaceutical formulations. The system consisted of an ACE 5 octadecylsilane (C18; 150 4.6 mm id), 5.0 m particle size column; methanol0.1 triethylamine (75 + 25, v/v), pH 5.3, mobile phase at a flow rate of 1.2 mL/min; and a diode array detector set at 220 nm. Specificity, linearity, precision, accuracy, and robustness were the parameters evaluated. The retention time for clopidogrel was 6.8 min. To estimate specificity, an aqueous sample solution was subjected to degradation by ultraviolet light and by acid, alkaline, and oxidation media. The peaks of degradation products did not interfere with the compound signal, and there was no interference when a placebo solution was analyzed. Linearity over a concentration range of 10.0 to 90.0 g/mL was shown (correlation coefficient = 0.9998). Low values of relative standard deviation indicated the adequate intraday and interday precision. The average recovery was found as 99.16. In the robustness test, small modifications to the mobile phase composition did not affect the determination of clopidogrel. The proposed method proved to be simple, fast, and cost efficient for the intended use. |
| Databáze: | OpenAIRE |
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