高效液相色谱法测定硫酸氢氯吡格雷片有关物质

Determemination of related substance in Clopidogrel Hydrogen Sulphate Tablet by HPLC

目的建立用高效液相色谱法测定硫酸氢氯吡格雷片有关物质的方法。方法色谱柱为ULTR ON ES-OVM(4.6 mm×150.0 mm,5μm),流动相为0.01 mol/L磷酸二氢钾溶液-乙腈(75∶25),流速1.0 mL/min,检测波长为220 nm,柱温为25℃,进样量为20μL。结果在该色谱条件下,硫酸氢氯吡格雷与各中间体、杂质分离良好,辅料对有关物质检测无干扰。结论本方法用于硫酸氢氯吡格雷片有关物质检测专属灵敏,方法可靠。

Objective To establish the method for determemination of related substance in Clopidogrel Hydrogen Sutphate Tablet. Methods ULTRON ES-OVM column （4.6 mm150.0 ram, 5 pLm） was used, mobile phase was 0.01 mol/L potassi- unto dihydrogen phosphate-aeetontrile （75：25）, the flow rate was 1.0 mL/min, detection wavelength was 220 nm, column temperature was 25~C. The sample amount was 20 jxL. Results In this chromatography condition, Clopidogrel Hydrogen Sulphate Tablet had a good separation from central substances and impurity substance; besides, excipients didn＇t interfere the results of related substance. Conclusion The method for determemination related substance of Clopidogrel Hydrogen Sulphate Tablet is exclusive, sensitive and reliable.