Uno Tsukasa, Yasui-Furukori Norio, Takahata Takenori, Sugawara Kazunobu, Tateishi Tomonori
Department of Pharmacy, Hirosaki University Hospital, Hirosaki, Japan.
J Chromatogr B Analyt Technol Biomed Life Sci. 2005 Feb 25;816(1-2):309-14. doi: 10.1016/j.jchromb.2004.11.052.
A simple and sensitive column-switching high-performance liquid chromatographic (HPLC) method for the simultaneous determination of lansoprazole, a proton pump inhibitor and its major metabolites: 5-hydroxylansoprazole and lansoprazole sulfone in human plasma. The test compounds were extracted from 1 mL of plasma using diethyl ether-dichloromethane (7:3, v/v) mixture and the extract was injected into a column I (TSK-PW precolumn, 10 microm, 3.5 mm x 4.6 mm i.d.) for clean-up and column I (C(18) STR ODS-II analytical column, 5 microm, 150 mm x 4.6 mm i.d.) for separation. The peak was detected by a ultraviolet detector set at a wavelength of 285 nm, and the total time for a chromatographic separation was approximately 25 min. The method was validated for the concentration range from 3 to 5000 ng/mL. Mean recoveries were 74.0% for lansoprazole, 68.3% for 5-hydroxylansoprazole, and 79.4% for lansoprazole sulfone. Intra- and inter-day relative standard derivatives were less than 6.1 and 5.1% for lansoprazole, 5.8 and 5.8% for 5-hydroxylansoprazole, 4.4 and 5.9% for lansoprazole sulfone, respectively, at the different concentration ranges. This method is suitable for use in therapeutic drug monitoring and pharmacokinetic studies, and provides use tool for measuring CYP2C19 activity.
一种简单灵敏的柱切换高效液相色谱（HPLC）法，用于同时测定质子泵抑制剂兰索拉唑及其主要代谢产物：人血浆中的5-羟基兰索拉唑和兰索拉唑砜。将测试化合物用乙醚-二氯甲烷（7:3，v/v）混合物从1 mL血浆中萃取，萃取物注入柱I（TSK-PW预柱，10μm，3.5 mm×4.6 mm内径）进行净化，再注入柱I（C(18) STR ODS-II分析柱，5μm，150 mm×4.6 mm内径）进行分离。用设定波长为285 nm的紫外检测器检测峰，色谱分离总时间约为25分钟。该方法在3至5000 ng/mL的浓度范围内得到验证。兰索拉唑的平均回收率为74.0%，5-羟基兰索拉唑为68.3%，兰索拉唑砜为79.4%。在不同浓度范围内，兰索拉唑的日内和日间相对标准偏差分别小于6.1%和5.1%，5-羟基兰索拉唑分别为5.8%和5.8%，兰索拉唑砜分别为4.4%和5.9%。该方法适用于治疗药物监测和药代动力学研究，为测定CYP2C19活性提供了有用工具。
