硫酸氢氯吡格雷的有关物质UPLC-MS测定方法的研究

目的研究建立硫酸氢氯吡格雷有关物质的UPLC-MS测定方法,考察其国产原料药有关物质。方法选用ULTRON ES-OVM手性色谱柱(15cm×4mm,5μm),流动相:0.03mol/L的醋酸氨溶液-乙腈(78:22),流速:0.8 mL/min,柱温:30℃,进样量:10μl。结果硫酸氢氯吡格雷的高温降解产物(杂质A,分子式:C15H14ClNO2S,分子量:307.8;杂质C,分子式:C16H16ClNO2S.H2SO4,分子量:419.90)及各已知杂质可有效分离。结论该方法稳定可靠,经与国外产品图谱对比,国产硫酸氢氯吡格雷的杂质少,质量较高。

UPLC-MS determination the related compound of clopidogrel Bisulfate

Objective To establish an UPLC-MS method for determination of the related Compound of Clopidogrel Bisulfate.Methods The separation was performed on a Ultron ES-OVM column(15cm×4mm,5μm),and the mobile phase consisted of 0.03mol·L-1 Ammonium acetate solution-Acetonitrile(78:22) at the flow rate of 0.8 mL·min-1.Column temperature:30℃,Injection volume:10μl.Results High temperature degradation products(Impurity A,Molecular formula:C15H14ClNO2S,Molecular weight:307.8;ImpurityC,Molecular formula:C16H16ClNO2S·H2SO4,Molecular weight:419.90) and known impurities of lopidogrel Bisulfate can be effectively separated.Conclusions The method developed is stable and reliable,By comparison Chromatogram with foreign products,Domestic Clopidogrel Bisulfate has the fewer impurities and high quality.