毛细管气相色谱-电子捕获法测定5-单硝酸异山梨酯血药浓度的研究

Determination of isosorbide5mononitrate in human plasma by capillary GC-ECD

目的：建立毛细管气相色谱电子捕获法（ＧＣＥＣＤ）测定人血浆中的５单硝酸异山梨酯（ＩＳ５ＭＮ）的浓度，为研究该药物在人体内的药动学和生物利用度提供依据。方法：以２单硝酸异山梨酯（ＩＳ２ＭＮ）为内标，血样经正己烷乙醚（１∶４）提取液两次萃取后，分离有机相，氮气下浓缩，甲苯溶解进样。采用ＡｌｔｅｃｈＳＥ３０毛细管柱（ＥＣＯＮＯ），１５ｍ×０．２５ｍｍ，程序升温测定血药浓度。结果：标准曲线在２４ｎｇ·ｍｌ－１～１２００ｎｇ·ｍｌ－１浓度内，ｒ＝０．９９９３，日内、日间变异ＲＳＤ为３．２９％～９．５０％，平均回收率为（１０１．６６±１．１１）％。结论：该方法测定血浆中５单硝酸异山梨酯浓度准确度高，专一性强，简便易行。

OBJECTIVE: To establish a capillary GCECD method for the determination of isosorbide5mononitrate in human plasma and study the pharmacokinetics of isosorbide5mononitrate in healthy volunteers. METHODS: Using isosorbide2mononitrate as the internal standard, plasma samples were extracted twice with a solvent of nhexane and ether (1∶4). The organic phase was separated and concentrated under nitrogen stream. RESULTS: The linear range of this method was 24 ng·ml-1～1 200 ng·ml-1, and the average recovery was (101.66±1.11)%. The coefficients of variation for interrun and intrarun was RSD=3.29%～9.50% (n=5). CONCLUSION: This method was simple, convenient, and sensitive. It could be used to determine isosorbide5mononitrate in vivo.