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目的:建立高效液相色谱-电喷雾离子化质谱联用测定人血浆中格拉司琼浓度的方法,用于盐酸格拉司琼口腔崩解片的人体药代动力学和生物等效性研究。方法:使用Hypurity C18柱(210 mm×150 mm,5μm),以10 mmol·L-1甲酸铵-0.1%甲酸-乙腈(20∶30∶50)为流动相,流速为0.2 mL·min-1,柱温为40℃,以二级质谱选择离子反应监测(SRM)方式扫描检测。结果:格拉司琼的线性浓度范围为0.1～59.8 ng·mL-1(r=0.9973),最小检出浓度为0.06 ng·mL-1。提取回收率大于70%,平均相对回收率在80%～120%范围内。日内与日间RSD均小于15%。结论:本法简便、灵敏,可用于格拉司琼的药物代谢动力学和生物等效性研究。
OBJECTIVE: To establish a method for the determination of granisetron in human plasma by high performance liquid chromatography-electrospray ionization mass spectrometry (HPLC-ESI / MS) and to study the pharmacokinetics and bioequivalence of granisetron hydrochloride orally disintegrating tablets. Methods: Hypurity C18 column (210 mm × 150 mm, 5 μm) was used with a mobile phase of 10 mmol·L -1 ammonium formate-0.1% formic acid-acetonitrile (20:30:50) at a flow rate of 0.2 mL · min -1 The column temperature was 40 ℃, and was detected by secondary ion-exchange mass spectrometry (SRM). Results: Granisetron linear concentration range of 0.1 ~ 59.8 ng · mL-1 (r = 0.9973), the minimum detectable concentration of 0.06 ng · mL-1. The extraction recovery was more than 70% and the average relative recovery was in the range of 80% ~ 120%. The RSDs are both less than 15% during and after the day. Conclusion: This method is simple, sensitive and can be used for the study of granisetron pharmacokinetics and bioequivalence.