Pav J W, Rowland L S, Korpalski D J
Department of Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877, USA.
J Pharm Biomed Anal. 1999 Jun;20(1-2):91-8. doi: 10.1016/s0731-7085(98)00312-4.
Nevirapine (VIRAMUNE) is a non-nucleoside reverse transcriptase inhibitor with activity against human immunodeficiency virus type 1 (HIV-1), currently marketed for the treatment of HIV-1 infected adults. A reverse phase HPLC-UV method was optimized and validated for the determination of nevirapine in human plasma, serum, milk and cerebrospinal fluid. The analyte was extracted from 250 microl of biofluid using a bonded silica solid phase extraction column, and resolved chromatographically on a reversed-phase, 15x0.46 cm i.d. 5 microm particle Supelco LC-8 analytical column with an isocratic mobile phase of 63% phosphate buffer (0.025 M, pH 6.0) with 1-butanesulfonic acid as anion-pair reagent: 21.5% methanol: 15.5% acetonitrile. The peaks were detected at a flow rate of 1.0 ml min(-1), at a wavelength of 280 nm, with a run time of 10 min. The assay was linear over a range of 25 to 10000 ng ml(-1). This method has been used for the clinical development of nevirapine.
奈韦拉平（维乐命）是一种非核苷类逆转录酶抑制剂，对1型人类免疫缺陷病毒（HIV-1）具有活性，目前已上市用于治疗HIV-1感染的成人。优化并验证了一种反相高效液相色谱-紫外法，用于测定人血浆、血清、乳汁和脑脊液中的奈韦拉平。使用键合硅胶固相萃取柱从250微升生物流体中提取分析物，并在反相15×0.46厘米内径、5微米粒径的Supelco LC-8分析柱上进行色谱分离，流动相为等度洗脱，由63%的磷酸盐缓冲液（0.025M，pH 6.0）、含1-丁烷磺酸作为离子对试剂、21.5%的甲醇和15.5%的乙腈组成。以1.0毫升/分钟的流速、280纳米的波长检测峰，运行时间为10分钟。该测定法在25至10000纳克/毫升的范围内呈线性。此方法已用于奈韦拉平的临床研发。
