Rezk Naser L, Crutchley Rustin D, Kashuba Angela D M
Clinical Pharmacology/Analytical Chemistry Core, Center for AIDS Research, 3320 Kerr Hall, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA.
J Chromatogr B Analyt Technol Biomed Life Sci. 2005 Aug 5;822(1-2):201-8. doi: 10.1016/j.jchromb.2005.06.019.
An accurate, sensitive and simple reverse-phase (RP) high-performance liquid chromatography (HPLC) assay for the simultaneous quantitative determination of emtricitabine and tenofovir in human blood plasma is described. Using 200 microL of plasma and BOND ELUT-C18 Varian columns, the solid phase extraction (SPE) method results in a clean baseline and high extraction efficiencies (100% for emtricitabine and 98.6% for tenofovir). An Atlantistrade mark dC-18 analytical column is used along with an 18 min linear gradient elution of phosphate buffer (pH 5.7) and methanol to provide sharp peaks for emtricitabine at 280 nm, tenofovir at 259 nm, and the internal standard 2',3'didoxyuridine (DDU) at 262 nm. The method was validated over the range of 10-10,000 ng/mL for both analytes, and is accurate (average accuracies of three different concentrations ranged from 98 to 105% for emtricitabine and 97 to 103% for tenofovir) and precise (within- and between-day precision ranged from 1.7 to 3.7% and 3.7 to 5.2%, respectively). This method is suitable for use in clinical pharmacokinetic studies and is nimble enough for therapeutic drug monitoring.
本文描述了一种准确、灵敏且简便的反相（RP）高效液相色谱（HPLC）分析法，用于同时定量测定人血浆中的恩曲他滨和替诺福韦。使用200微升血浆和BOND ELUT-C18瓦里安柱，固相萃取（SPE）方法可获得干净的基线和高萃取效率（恩曲他滨为100%，替诺福韦为98.6%）。使用Atlantistrade mark dC-18分析柱，以及磷酸盐缓冲液（pH 5.7）和甲醇的18分钟线性梯度洗脱，可在280纳米处为恩曲他滨、259纳米处为替诺福韦以及262纳米处为内标2',3'-二脱氧尿苷（DDU）提供尖锐的峰。该方法在两种分析物的10 - 10,000纳克/毫升范围内进行了验证，准确（恩曲他滨三种不同浓度的平均准确度范围为98%至105%，替诺福韦为97%至103%）且精密（日内和日间精密度分别为1.7%至3.7%和3.7%至5.2%）。该方法适用于临床药代动力学研究，并且灵活到足以用于治疗药物监测。
