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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: To establish an RP-HPLC method for ondansetron in human plasma for human pharmacokinetics study of ondansetron. Methods: The plasma samples were deproteinized with acetonitrile, centrifuged, the supernatant was taken and evaporated to dryness, dissolved with a small amount of mobile phase, for injection analysis. The column was equipped with an Alltima C_ (18) column (4.6 mm × 250 mm, 5 μm) and the precolumn was Beckman-ultrasphere ODS (4.6 mm × 45 mm, 5 μm) 25) as mobile phase at a flow rate of 1 mL · min ~ (-1) at 310 nm with a sensitivity of 0.0001 AUFS. The plasma concentration-time course of a single oral dose of ondansetron 8 mg was measured in 10 healthy volunteers. Results: The lowest limit of detection was 0.5 ng · mL -1 and the linear range was 1 ~ 80 ng · mL -1 (r = 0.992 2). The intra- and inter-day precision was less than 10% The rate was 88.7% ~ 98.2%, in line with biological sample analysis requirements. Conclusion: The method is simple, accurate and sensitive. It can be used to study the pharmacokinetics of ondansetron tablets.