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建立了液相色谱-串联质谱法测定人血浆中的依非韦伦。以多西他赛为内标,采用ESI源正离子模式、多反应监测(MRM)进行定量分析。依非韦伦在0.05~10mg/ml范围内线性关系良好,方法回收率为96.9%~100.1%,批内RSD≤4.6%,批间RSD≤6.1%。考察了22例男性健康志愿者单次空腹口服依非韦伦片(受试制剂和参比制剂)的生物等效性。两者的AUC和c_(max)无显著性差异,受试制剂的平均相对生物利用度F为(98.75±35.41)%,表明两制剂生物等效。
A liquid chromatography-tandem mass spectrometry was developed for the determination of efavirenz in human plasma. To docetaxel as an internal standard, using ESI source positive ion mode, multiple reaction monitoring (MRM) for quantitative analysis. The linear range of efavirenz in the range of 0.05-10 mg / ml was good. The recovery was 96.9% -100.1%. The intra-assay RSD was less than 4.6% and the inter-assay RSD was less than or equal to 6.1%. The bioequivalence of a single fasting oral effeverine tablet (test and reference) was determined in 22 male, healthy volunteers. There was no significant difference between AUC and cmax, and the average relative bioavailability F of the test preparation was (98.75 ± 35.41)%, indicating that the two preparations were bioequivalent.