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目的:建立液-质联用法测定人血浆中磷霉素钙的浓度,研究磷霉素钙的人体药动学及生物等效性。方法:血浆样品中加入内标阿德福韦,经乙腈蛋白沉淀,SB-Aq C18色谱柱进行分离,流动相流速为1.0mL.min-1,梯度洗脱方式,采用多反应监测(MRM)的负离子方式检测。结果:在100~25 000μg.L-1范围内呈良好的线性关系,日内及日间精密度(RSD)小于8%。受试制剂和参比制剂的tmax分别为(1.8±0.2)h和(2.4±0.5)h,Cmax分别为(6 034.0±1 540.9)μg.L-1和(6 182.5±1 221.4)μg.L-1,AUC0-t分别为(43 755.6±7 198.0)μg.h.L-1和(43 720.1±9 134.2)μg.h.L-1。结论:本法准确,灵敏无杂质干扰。两种制剂生物等效。
OBJECTIVE: To establish a method for the determination of fosfomycin calcium in human plasma by liquid chromatography-mass spectrometry, and to study the pharmacokinetics and bioequivalence of fosfomycin calcium. Methods: Adefovir was added to the plasma samples and precipitated with acetonitrile. The mobile phase was separated on a SB-Aq C18 column with a mobile phase flow rate of 1.0 mL · min-1. The gradient elution was carried out using multiple reaction monitoring (MRM) Negative ion detection. Results: There was a good linear relationship in the range of 100 ~ 25 000 μg.L-1, and the intra- and inter-day precision (RSD) was less than 8%. The tmax of test and reference preparations were (1.8 ± 0.2) h and (2.4 ± 0.5) h, respectively, with Cmax values of (6 034.0 ± 1 540.9) μg.L-1 and (6 182.5 ± 1 221.4) μg, respectively. L-1 and AUC0-t were (43 755.6 ± 7 198.0) μg.hL-1 and (43 720.1 ± 9 134.2) μg.hL-1, respectively. Conclusion: This method is accurate and sensitive without impurity interference. Both formulations are bioequivalent.