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.
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2006年第12期833-835,共3页
Chinese Journal of Pharmaceuticals