Sripalakit Pattana, Kongthong Bungon, Saraphanchotiwitthaya Aurasorn
Department of Pharmaceutical Chemistry and Pharmacognosy, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand.
J Chromatogr B Analyt Technol Biomed Life Sci. 2008 Jun 15;869(1-2):38-44. doi: 10.1016/j.jchromb.2008.05.017. Epub 2008 May 16.
An analytical method based on high-performance liquid chromatographic (HPLC) was developed for the determination of montelukast in human plasma using mefenamic acid as an internal standard. After precipitation of plasma proteins with acetonitrile, chromatographic separation was carried out using a Zorbax Eclipse XDB C8 (150 mm x 4.6 mm i.d., 5 microm) with mobile phase consisted of methanol-acetonitrile-0.04M disodium hydrogen orthophosphate (22:22:56, v/v, pH 4.9). The wavelengths of fluorescence detection were set at 350 nm for excitation and 450 nm for emission. The linearity was confirmed in the concentration range of 5-1000 ng/ml in human plasma. Intra- and inter-day accuracy determined from quality control samples were 101.50 and 107.24%, and 97.15 and 100.37%, respectively. Intra- and inter-day precision measured as coefficient of variation were < or =4.72 and < or =9.00%, respectively. Extraction recoveries of drug from plasma were >48.14%. The protocol herein described was employed in a pharmacokinetic study of tablet formulation of montelukast in healthy Thai male volunteers.
建立了一种基于高效液相色谱（HPLC）的分析方法，以甲芬那酸为内标物测定人血浆中的孟鲁司特。用乙腈沉淀血浆蛋白后，使用Zorbax Eclipse XDB C8柱（150 mm×4.6 mm内径，5μm）进行色谱分离，流动相由甲醇 - 乙腈 - 0.04M磷酸氢二钠（22:22:56，v/v，pH 4.9）组成。荧光检测波长设定为激发波长350 nm和发射波长450 nm。在人血浆5 - 1000 ng/ml的浓度范围内确认了线性关系。由质量控制样品测定的日内和日间准确度分别为101.50%和107.24%，以及97.15%和100.37%。以变异系数衡量的日内和日间精密度分别≤4.72%和≤9.00%。从血浆中提取药物的回收率>48.14%。本文所述的方案用于健康泰国男性志愿者中孟鲁司特片剂制剂的药代动力学研究。
