Sun Jianguo, Wang Guangji, Wang Wei, Zhao Shuai, Gu Yi, Zhang Jinwen, Huang Mingwen, Shao Fen, Li Hao, Zhang Qi, Xie Haitang
Center of Pharmacokinetics, Key Laboratory of Drug Metabolism and Pharmacokinetics, China Pharmaceutical University, Nanjing, China.
J Pharm Biomed Anal. 2005 Sep 1;39(1-2):217-24. doi: 10.1016/j.jpba.2005.03.041.
To support the pharmacokinetic and bioavailability study of an extended-release loratadine (LOR)/pseudoephedrine sulfate (PES) tablet, a high performance liquid chromatographic-electrospray ionisation-mass spectrometric method (LC-MS) was developed for the simultaneous determination of LOR and PES in human plasma. Diazepam (DP) and phenylpropanolamine (PPA) were used as internal standards for LOR and PES, respectively. Analytes were extracted from alkalized human plasma by liquid/liquid extraction using ethyl ether. Chromatographic separation was performed on an ODS column at flow rate of 0.2 ml/min. The total chromatographic run time was 10.5 min with the retention time of 7.1 min and 6.2 min for LOR and DP, respectively, and 2.2 min for both of PES and PPA. The LOQ was 10 pg/ml and 50 pg/ml for LOR and PES, respectively. The method is accurate and precise enough for its intended purpose.
为支持氯雷他定(LOR)/硫酸伪麻黄碱(PES)缓释片的药代动力学和生物利用度研究,开发了一种高效液相色谱 - 电喷雾电离 - 质谱法(LC - MS),用于同时测定人血浆中的LOR和PES。地西泮(DP)和苯丙醇胺(PPA)分别用作LOR和PES的内标。通过使用乙醚的液 - 液萃取从碱化的人血浆中提取分析物。在ODS柱上以0.2 ml/min的流速进行色谱分离。总色谱运行时间为10.5分钟,LOR和DP的保留时间分别为7.1分钟和6.2分钟,PES和PPA的保留时间均为2.2分钟。LOR和PES的定量下限分别为10 pg/ml和50 pg/ml。该方法对于其预期目的具有足够的准确性和精密度。