HPLC-UV法测定环磷酰胺血药浓度及其临床应用

目的：建立测定环磷酰胺血药浓度的高效液相色谱法。方法：血浆样品经碱性乙腈沉淀蛋白后,以乙腈-水溶液（30∶70）为流动相,流速1.2 mL/min,采用XterraRP18色谱柱分离,在197 nm波长下进行检测,柱温30℃。结果：环磷酰胺在1.0～32.0 mg/L浓度范围内与峰面积呈良好的线性关系（r=0.9999,n=5）,提取回收率90.07%～91.44%,日内、日间精密度（RSD）均〈10%。血浆中环磷酰胺最低检测浓度为0.1 mg/L。结论：本文建立的方法灵敏度高,选择性好,简便、快速、准确,适用于临床样本环磷酰胺的血浆浓度测定和药代动力学研究,可为临床实施个体化给药提供参考。

Determination of Cyclophosphamide in Human Plasma by HPLC-UV and Correlation Research between Plasma Concentration and Clinical Efficacy

Objective： To determine human plasma cyclophosphamide concentration by high-performance liquid chromatography.Methods： Plasma samples were deproteinized by alkaline acetonitrile with acetonitrile-water（ 30∶ 70） as mobile phase; flow rate was1. 2 mL /min; Xterra RP18 column was used; wavelength was set at 197 nm; column temperature was 30 ℃. Results： The linear range of cyclophosphamide plasma concentration was 1. 0 ～ 32. 0 mg /L; there was a good linear relationship（ r = 0. 9999,n = 5）. The extraction recovery was 90. 07% ～ 91. 44%. The intra-and inter-day RSD were less than 10%. Conclusions： This method is accurate,sensitive and suitable for determination of high dose of CTX concentration in plasma and pharmacokinetic studies. It will provide reference of individualizing dosage regimens.