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目的:建立测定人血浆中赖诺普利浓度的液相色谱-串联质谱(LC-MS-MS)法,评价赖诺普利试验片与参比片的生物等效性。方法:20名志愿者随机单剂量双交叉口服赖诺普利试验片和参比片10 mg,采用沉淀蛋白法预处理血浆样品后,进行LC-MS-MS法测定。结果:试验片和参比片中药物主要药动学参数如下:cmax分别为(54±s 21)和(53±23)μg·L-1,tmax分别为(6．4±1．4)和(6．7±1．1)h,AUC0～36分别为(569±244)和(566±269)μg·h·L-1,AUC0～∞分别为(589±250)和(587±268)μg·h·L-1;按AUC0～36计算,赖诺普利试验片的相对生物利用度为(102±8)％。结论:本方法操作简单,灵敏度、准确度、精密度和定量分析线性关系均良好,符合生物样品测定要求;经统计学检验,试验片与参比片生物等效。
OBJECTIVE: To establish a liquid chromatography-tandem mass spectrometry (LC-MS-MS) method for the determination of lisinopril in human plasma to evaluate the bioequivalence of lisinopril and reference tablets. METHODS: Twenty volunteers were randomized to receive a lisinopril test and a reference 10 mg single-dose, double-crossover, and plasma samples were pretreated with the precipitated protein method and analyzed by LC-MS-MS. RESULTS: The main pharmacokinetic parameters of the test and reference tablets were as follows: cmax were (54 ± s 21) and (53 ± 23) μg · L -1, respectively, and tmax were (6.4 ± 1.4) And (6.7 ± 1.1) h, AUC0 ~ 36 were (569 ± 244) and (566 ± 269) μg · h · L-1, respectively. The AUC0 ~ ∞ were (589 ± 250) and 268) μg · h · L-1; The relative bioavailability of lisinopril test strips was (102 ± 8)% based on AUC0-36. Conclusion: The method has simple operation, good linearity in sensitivity, accuracy, precision and quantitative analysis, which meets the requirements of biological sample determination. The test results are bioequivalent to reference tablets by statistical test.