摘要
目的:建立测定人体血浆中氨磺必利高效液相色谱法,测定健康志愿者口服氨磺必利片48 h内血药浓度,进行药动学研究。方法:采用10%三氯醋酸直接沉淀提取血浆,固定相为C18,以庚烷磺酸钠醋酸溶液(pH 4.85)-乙腈(80∶20)为流动相,荧光检测波长为λex=280 nm,λem=370 nm。结果:氨磺必利线性范围为5～800 ng·mL-1(r=0.9997),低、中、高3个浓度平均方法回收率分别为105.1%、105.4%、101.3%,日内、日间精密度RSD均<4%;AUC0～∞为(3545.74±1199.58)ng·h·mL-1,AUC0～t为(3348.50±1161.27)ng·h·mL-1,C max为(457.69±232.62)ng·mL-1,T max为(4.15±1.31)h,t1/2为(10.77±5.77)h。结论:本法简便、快速、经济、准确,可用于测定人血浆中氨磺必利的浓度及药动学研究。
Objective ：To establish an HPLC method for the determination of amisulpride levels in human plasma, determine the amisulpride plasma concentration in healthy volunteers within 48 hours after oral administration of amisulpride tablets, and study on pharmacokineties. Methods：The amisulpride was extracted from plasma by 10% triehloroacetie acid. Chromatographic separation has been achieved on C18 column with sodium heptanesulfonate - acetic acid （pH 4. 85 ）and methyl cyanides （80： 20）as the mobile phase. The fluorescence detection was used to de- termine amisulpride atλex = 280 nm and λem = 370 nm. Results：The linear range was 5 - 800 ng . mL-1 （r = 0.9997）. The average method recovery of low, middle and high concentration was 105.1%, 105.4%, and 101.3% ,respectively. RSDs of inter - and intra -day precision were both less than 4%. AUC0-∞ was（3545.74 ± 1199.58） ng.h . mL- 1, AUC0-t was （ 3348.50 ± 1161.27 ） ng . h . mL- 1 , Cmax was （ 457.69 ± 232.62 ）ng . mL -1, Tmax was （4. 15 ± 1.31 ） h, t1/2 was （ 10. 77 ± 5.77 ） h. Conclusion ： The method is simple, rapid, economical and accurate for determination of amisulpride in human plasma and pharmaeokinetie study.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2013年第9期1486-1490,共5页
Chinese Journal of Pharmaceutical Analysis
关键词
氨磺必利
高效液相色谱法
荧光检测
血药浓度
血浆样品测定
药动学研究
amisulpride
HPLC
fluorescence detection
plasma drug concentration
plasma sample determination
pharmacokinetic study
