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目的建立人血浆中磺胺甲噁唑及其代谢产物的RP-HPLC测定法,研究磺胺甲噁唑及其代谢产物N4-乙酰磺胺甲噁唑的药代动力学特征。方法血样经高氯酸预处理后,进行HPLC分析,色谱柱为Lichrospher C18(5μm,250 mm×4.6 mm),流动相为乙腈-水-冰乙酸-三乙胺(38:62:0.4:0.3,v/v),流速为1.0 ml/min,检测波长为240 nm。结果磺胺甲噁唑和N4-乙酰磺胺甲噁唑分别在1～160μg/ml和0.5～20μg/ml的范围内浓度与峰面积线性关系良好,定量限分别为1μg/ml和0.5μg/ml,日内精密度分别为0.91%～6.83%和1.80%～7.66%,日间精密度分别为2.12%～6.09%和4.16%～8.15%,回收率分别为95.9%～106.0%和98.8%～110.3%。结论建立的人血浆中磺胺甲噁唑及其代谢产物的RP-HPLC分析方法灵敏、准确、简便,适合于磺胺甲噁唑及其代谢产物N4-乙酰磺胺甲噁唑的药代动力学研究。
OBJECTIVE To establish a RP-HPLC method for the determination of sulfamethoxazole and its metabolites in human plasma and study the pharmacokinetics of sulfamethoxazole and its metabolite N4-acetylsulfamethoxazole. Methods The blood samples were pretreated with perchloric acid and analyzed by HPLC. The chromatographic column was Lichrospher C18 (5 μm, 250 mm × 4.6 mm). The mobile phase consisted of acetonitrile-water-glacial acetic acid-triethylamine , v / v) at a flow rate of 1.0 ml / min with a detection wavelength of 240 nm. Results Sulfamethoxazole and N4-acetylsulfamethoxazole had good linear relationship with the peak area in the range of 1 ~ 160μg / ml and 0.5 ~ 20μg / ml with the limits of quantitation of 1μg / ml and 0.5μg / ml, The intra-day precision was 0.91% -6.83% and 1.80% -7.66% respectively. The intra-day precision was 2.12% -6.09% and 4.16% -8.15% respectively. The recoveries were 95.9% -106.0% and 98.8% -110.3% . Conclusion The RP-HPLC method for the determination of sulfamethoxazole and its metabolites in human plasma is sensitive, accurate and simple and suitable for the pharmacokinetics study of sulfamethoxazole and its metabolite N4-acetylsulfamethoxazole.