检测人血浆中利福平及其主要代谢物25-去乙酰利福平浓度的高效液相色谱法

HighPerformance Liquid Chromatography Assay for Detection of Rifampicin and 25Desacetylrifampicin in Human Plasma

目的：建立检测人血浆中利福平及其主要代谢物２５－去乙酰利福平浓度的高效液相色谱法，并用于药代动力学研究。方法：所用色谱柱是ＺｏｒｂａｘＯＤＳ（５μｍ，４．６ｍｍ×２５０ｍｍ），采用梯度洗脱，流动相Ａ和Ｂ由甲醇、乙腈和０．１ｍｏｌ·Ｌ－１ＮａＨ２ＰＯ４组成（流动相Ａ三者的体积比为３５∶２５∶４０，Ｂ为５０∶２５∶２５），以利福贲丁作为内标物，检测波长为３３６ｎｍ。结果：血浆标准曲线为：利福平，ＣＲＭＰ＝６．９１８Ａｐ／Ａｉｎ－０．０６４，ｒ＝０．９９９９；２５－去乙酰利福平，ＣＤＥＳ＝１０．９１Ａｄ／Ａｉｎ－０．０２９，ｒ＝０．９９９７。两者从血浆提取的平均回收率分别为９１．８％和８４．７％。批内和批间ＲＳＤ均＜８．６％。结论：本法可用于药代动力学和临床研究。

bjective: The purpose of the study was to develope a method for determination of Rifampicin and 25Desacetylrifampicin with highperformance liquid chromatography in human plasma for pharmacokinetic research. Methods: A Zorbax ODS column and mobile phases that were composed of methanol, acetontrile and 0.1molL-1 NaH2PO4,were used for setting an ultraviolet detection (336nm). Rifapentine was chosen as an internal standard. Results: CRMP=6.918 Ap/Ain -0.064,r=0.9999;CDES=10.91 Ad/Ain-0.029,r= 0.9997. RSDs of intrabatch and interbatch assays were lower than 8.6%. The average recoveries of Rifampicin and 25Desacetylrifampicin from plasma were 91.8% and 84.7%,respectively. Conclusion: This method could be used in pharmacokinetic and clinical studies.