人血浆中辛伐他汀的HPLC-MS/MS测定  

Determination of Simvastatin in Human Plasma by HPLC-MS/MS

作　　者：张红[1] 徐文炜[1] 胡晓[1] 李艳艳[1] 熊玉卿[1] 

机构地区：[1]江西医学院临床药理研究所,江西南昌330006

出　　处：《中国医药工业杂志》2006年第12期833-835,共3页Chinese Journal of Pharmaceuticals

摘　　要：建立了HPLC-MS/MS法测定人血浆中辛伐他汀的浓度,并以24名健康志愿者进行了两种辛伐他汀片的生物等效性研究。采用C18柱,流动相为0.5%甲酸溶液和乙腈,梯度洗脱。质谱采用电喷雾离子化,定量分析离子分别为m/z482.0→441.0(辛伐他汀)和m/z468.0→427.0(洛伐他汀,内标)。辛伐他汀在0.2～50ng/ml范围内线性关系良好。方差分析和双单侧t检验表明两制剂生物等效。A HPLC-MS/MS method was established for the determination of simvastatin in human plasma, and the bioequivalence of simvastatin tablets of two brands were investigated in 24 healthy male volunteers. A C18 column was used with the mobile phase of 0.5 % formic acid and acetonitrile by gradient elution. The electropray ionization was used, m/z 482.0 → 441.0 （simvastatin） and m/z 468.0→ 427.0 （lovastatin, internal standard）. The calibration curve was linear in the range of 0.2 - 50ng/ml. The results of variance analysis and two one-side t test showed that two preparations were bioequivalent.

关 键 词：辛伐他汀 液相色谱-串联质谱 药物动力学 测定 

分 类 号：R969[医药卫生—药理学] O657.72[医药卫生—药学]