Wang Yongsheng, Zhao Xiaoping, Zhong Jiao, Chen Yan, Liu Xiaoquan, Wang Guangji
Key Laboratory of Drug Metabolism and Pharmacokinetics, China Pharmaceutical University, Nanjing 210009, People's Republic of China.
Biomed Chromatogr. 2006 Dec;20(12):1375-9. doi: 10.1002/bmc.708.
A simple, rapid and reliable high-performance liquid chromatographic method was developed and validated for the determination of pirfenidone and its major metabolites in rat plasma. Plasma proteins were precipitated with perchloric acid (10%, v/v) and the supernatant after centrifugation was determined using high-performance liquid chromatography. The analysis was carried out on a Lichrospher C(18) column (250 x 4.6 mm i.d., 5 microm). The mobile phase consisted of acetonitrile-water containing 0.2% acetic acid (23:77, v/v) at a flow-rate of 1 mL/min. The eluant was detected at 310 nm. The calibration curves were linear over a concentration range from 0.15 to 76.67 microg/mL. The accuracy (relative error) of the assay ranged from -2.6 to 7.9% and the precision (coefficient of variation) was less than 4.5%. The established method has been successfully applied to a pharmacokinetic study of pirfenidone following a single oral dose to rats.
建立并验证了一种简单、快速且可靠的高效液相色谱法，用于测定大鼠血浆中吡非尼酮及其主要代谢物。用高氯酸（10%，v/v）沉淀血浆蛋白，离心后的上清液用高效液相色谱法测定。分析在Lichrospher C(18)柱（250×4.6 mm内径，5μm）上进行。流动相由含0.2%乙酸的乙腈-水（23:77，v/v）组成，流速为1 mL/min。洗脱液在310 nm处检测。校准曲线在0.15至76.67μg/mL的浓度范围内呈线性。该测定法的准确度（相对误差）范围为-2.6%至7.9%，精密度（变异系数）小于4.5%。所建立的方法已成功应用于大鼠单次口服吡非尼酮后的药代动力学研究。
