摘要
目的建立RP—HPLC-荧光色谱法测定人血浆中盐酸格拉司琼的含量。方法以20名健康男性志愿者为研究对象，采用交叉给药方案，分别单剂量口服2mg的试验制剂和参比制剂。采取液-液萃取法处理血浆样品，色谱柱为Diamonsil C18（150mm×4．6mm，5μm），流动相为甲醇-0．5％三乙胺水溶液（pH4．0）（46：54），激发和发射波长分别为305nm和360nm，流速为1.0mL·min^-1。结果盐酸格拉司琼在0．078～20．08ng·mL^-1线性关系良好（r=0．9994），最低检测限为1．95×10^2ng·mL^-1，日内RSD〈1．9％，日间RSD〈3．3％，平均提取回收率为85．7％，平均方法回收率为100．0％。结论该方法快速、准确，适用于盐酸格拉司琼的临床药动学研究和血药浓度监测。
OBJECTIVE A simple RP-HPLC method with fluorescence detection was established for the determination of granisetron hydrochloride in human plasma. METHODS Twenty healthy volunteers were given a single oral dose of granisetron hydrochloride dispersible tablet or tablet （control） in a randomized crossover study. The samples were extracted by liquid-liquid extraction. A Diamonsil C18column was used with the mobile phase of methanol-0.5% triethylamine（ pH 4.0 ） （46：54 ） and the flow rate was 1.0 mL ·min^ -1. The excitation and emission wavelengths of fluorescence detection were 305 nm and 360 nm, respectively. RESULTS The calibration curve was linear in the concentration range of 0. 078 - 20.08 ng · mL^-1 and the detective limit of concentration was 1.95 × 10^-2 ng · mL^-1. The intra-day RSD and inter-day RSD were less than 1.9% and 3.3% ,respectively. The average extraction recovery was 85.7%. The average recovery of the method was 100.0%. CONCLUSION The method is sensitive and accurate for the determination of granisetron hydrochloride in human plasma.
出处
《中国现代应用药学》
CAS
CSCD
北大核心
2008年第4期323-325,共3页
Chinese Journal of Modern Applied Pharmacy
