摘要
目的建立灵敏的液相色谱-串联质谱(LC-MS/MS)法测定大鼠血浆中吡非尼酮的浓度。方法血浆样品采用乙腈蛋白沉淀方法,色谱柱为Dikma Diamonsil C18;以0.1%甲酸-乙腈(45:55,v/v)为流动相;流速为0.4 m L·min-1;柱温为30℃。结果吡非尼酮血药浓度在5-2000 ng·m L-1内线性关系良好(r=0.9995),最低检测限为5 ng·m L-1;日内、日间RSD均≤10%,高、中、低3种浓度的回收率均在93%左右。6只SD大鼠单剂量口服给予吡非尼酮后药动学参数分别为:Cmax(1354.3±143.5)ng·m L-1;t1/2(2.21±0.24)h;AUC0-t(3474.6±982.5)h·ng·m L-1;AUC0-∞(3687.4±992.4)h·ng·m L-1。结论本方法简便、准确、灵敏、专属性强,同样适用于人血浆中吡非尼酮浓度的测定及其药动学研究,对于评价吡非尼酮疗效和安全性有重要意义。
Objective To establish a sensitive LC-MS/MS method to determine pirfenidone in rat plasma. MethodsChromatographic analysis was carried out on a Dikma Diamonsil C18 column with the mobile phase of 0.1% formic acid and acetonitrile(45 :55, v/v) at flow rate of 0.4 m L·min- 1. The temperature of column was 30 ℃. ResultsThe calibration was linear at 5- 2000 ng·m L- 1 for pirfenidone. The inter- and intra-day precision was less than 10%. The recovery was 93%. The pharmacokinetic parameters were: Cmax(1354.3±143.5) ng·m L-1; t1/2(2.21±0.24) h; AUC0 - t(3474.6±982.5) h·ng·m L- 1; and AUC0 -∞(3687.4±992.4) h·ng·m L- 1. Conclusion This simple, accurate, sensitive and specific method can be used in routine clinical practice to monitor pirfenidone concentrations in human plasma.
出处
《中南药学》
CAS
2015年第9期919-922,共4页
Central South Pharmacy