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目的:建立大鼠血浆中瑞格列奈浓度的HPIC测定方法,并研究瑞格列奈在大鼠体内药物动力学行为。方法:血浆样品经酸化后,加入内标物,用醋酸乙酯提取,色谱柱为Kromasil C_(18)(150mm×4.6 mm,5 μm),流动相为0.1mol·L~(-1)柠檬酸-醋酸钠缓冲液(pH 4.0)-甲醇(27:73),流速为1.0mL·min~(-1),紫外检测波长243 nm,进样量20μL。测定了12只受试大鼠单剂量灌服瑞格列奈4 mg后血药浓度-时间过程。结果:最低检测为2.5 ng·mL~(-1),相对回收率平均为97.85%,日间和日内的变异系数小于5,线性范围为2.5～100 ng·mL~(-1),符合生物样品分析的要求。受试大鼠灌服瑞格列奈片4 mg后,估算的末端相半衰期(0.83±0.16)h,t_(max)(0.75±0.41)h,C_(max)(48.6±15.7)ng·mL~(-1)。结论:建立的HPLC方法适合于血浆中瑞格列奈浓度的测定及药动学研究。
OBJECTIVE: To establish a HPLC method for determining the concentration of repaglinide in rat plasma and to study the pharmacokinetics of repaglinide in rats. Methods: The plasma samples were acidified, then the internal standard was added and extracted with ethyl acetate. The column was Kromasil C18 (150 mm × 4.6 mm, 5 μm) and the mobile phase consisted of 0.1 mol·L -1 lemon The pH was 4.0 and methanol (27:73). The flow rate was 1.0 mL · min -1. The UV detection wavelength was 243 nm and the injection volume was 20 μL. The plasma concentration-time course of 12 rats were measured after a single dose of repaglinide 4 mg. Results: The minimum detectable concentration was 2.5 ng · mL -1, the relative recovery was 97.85%, the coefficient of variation (CV) was less than 5 during day and day, and the linear range was 2.5-100 ng · mL -1. Sample analysis requirements. The test rats were fed with repaglinide 4 mg, the estimated terminal phase half-life (0.83 ± 0.16) h, t max (0.75 ± 0.41) h and C max (48.6 ± 15.7) ng · mL ~ (-1). Conclusion: The established HPLC method is suitable for the determination of plasma repaglinide concentration and pharmacokinetics.