HPLC in determination of effective contents and related substances in clopidogrel hydrogen sulfate produced by 3 manufacturers / 第二军医大学学报

ABSTRACT

Objective To establish a high performance liquid chromatography(HPLC) method for quantitative determination of S-clopidogrel and its related substance R-clopidogrel in clopidogrel tablets, and to compare their contents between clopidogrel tablets produced by three different manufacturers. Methods An ULTRON ES-OVM column (4.6 mm × 150 mm,5 μm) was used in this study. The mobile phase consisted of a mixture of acetonitrile and 0.01 mol/L potassium dihydrogen phosphate solution (2080). The flow-rate was 1 mL/min, with the column temperature being 17°C and the UV detection wave lenth being 220 nm. Results S-clopidogrel and its related substance R-clopidogrel were in good linear relationship within 50-117 mg/L and 1.52-30.04 mg/L, respectively (both r=0.999 8). The precision of our method was satisfactory and the average recoveries were 99.7% and 98.8%, respectively. The test solution remained stable for 12 h. S-clopidogrel and R-clopidogrel in clopidogrel tablets produced by three manufacturers were in line with the quality requirements of pharmacopoeia. Conclusion Our method is accurate and has good specificity. It can be used for the quality control of clopidogrel tablets.