摘要
目的:建立人血浆中昂丹司琼的RP-HPLC测定法,用于昂丹司琼片的人体药代动力学研究。方法:血浆样品加乙腈脱蛋白后,离心,取上清液,挥干,用少量流动相溶解,供进样分析。采用Alltima C_(18)柱(4.6 mm×250 mm,5 μm),预柱:Beckman-ultrasphere ODS(4.6 mm×45 mm,5μm),以醋酸钠缓冲液(pH=4.2)-乙腈(75:25)为流动相,流速:1mL·min^(-1),于310 nm波长处检测,灵敏度:0.0001 AUFS。测定了10名健康志愿者单剂量口服昂丹司琼8 mg后的血药浓度-时间过程。结果:最低检测限达0.5 ng·mL^(-1),线性范围为1～80 ng·mL^(-1)(r=0.992 2),日内和日间精密度均小于10％,平均回收率为88.7％～98.2％,符合生物样品分析要求。结论:本法操作简单,准确,灵敏度高,可用于昂丹司琼片的药代动力学研究。
Objective: The purpose is to establish a RP - HPLC method for investigating the pharmacokinetics of ondansetron in human plasma. Method: Ondansetron was extracted from plasma with acetonitrile, evaporate to dryness and dissolve the residue in a little mobile phase for the determination. The RP - HPLC method was performed with a Alltima C18 (4. 6 mm× 45 mm, 5 μm) , pretective column: Beckman - ultrasphere ODS (4. 6 mm×250 mm, 5μm) , and the mobile phase consisted of pH 4. 2 sodium acetate buffer and acetonitrile in the ratio of 75: 25, flow rate: 1.0 mL· min-1 . Ondansetron is detected by UV absorbance at 310 nm. Sensitivity; 0.000 1 AUFS. Results: The regression line was linear in the concentration range of 1- 80 ng· mL-1 (r = 0. 992 2) and the limit of detection was 0.5 ng · mL -1 . The recoveries of ondansetron from plasma were more than 85% and the RSD of intra - day and inter - day was less than 10% . The plasma concentration of ten healthy subjects after an oral dose of 8 mg ondansetron tablet was detected. Conclusion: The assay method is simple, accuracy, sensitive and applicable for pharmacokinetic study of ondansetron.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2002年第5期386-388,共3页
Chinese Journal of Pharmaceutical Analysis
