Miyabayashi T, Okuda T, Motohashi M, Izawa K, Yashiki T
Drug Analysis and Pharmacokinetics Research Laboratories, Takeda Chemical Industries, Ltd., Osaka, Japan.
J Chromatogr B Biomed Appl. 1996 Feb 23;677(1):123-32. doi: 10.1016/0378-4347(95)00405-x.
A sensitive high-performance liquid chromatographic (HPLC) method is described for the determination of a new potent antihypertensive agent, TCV-116, and its two metabolites (M-I and M-II) in human serum or urine. After pre-treatment of the specimens, the analytes were determined using a column switching technique, except for the metabolites in urine which were determined by gradient elution mode HPLC. The quantitation limits for TCV-116, M-I and M-II were all 0.5 ng/ml in serum, and 0.5, 10 and 110 ng/ml in urine, respectively. The methods were applied to clinical trials of TCV-116.
本文描述了一种灵敏的高效液相色谱(HPLC)方法,用于测定人血清或尿液中一种新型强效抗高血压药物TCV-116及其两种代谢物(M-I和M-II)。样品经预处理后,除尿液中的代谢物采用梯度洗脱模式HPLC测定外,其余分析物均采用柱切换技术测定。TCV-116、M-I和M-II在血清中的定量限均为0.5 ng/ml,在尿液中的定量限分别为0.5、10和110 ng/ml。该方法应用于TCV-116的临床试验。