School of Pharmaceutical Sciences, Zhengzhou University, 100 Science Road, Zhengzhou 450001, PR China.
J Chromatogr B Analyt Technol Biomed Life Sci. 2013 Aug 1;932:88-91. doi: 10.1016/j.jchromb.2013.06.007. Epub 2013 Jun 14.
This investigation describes a precise and accurate stereoselective HPLC method for the simultaneous determination of indapamide enantiomers in whole blood to follow its pharmacokinetics in rats up to 24h after single oral dosing. Enantiomeric resolution was achieved on a cellulose tris (3,5-dichlorophenylcarbamate) column known as Chiralpak IC, with UV detection at 240nm, and the mobile phase consisted of n-hexane and isopropanol (70:30, v/v). Using the chromatographic conditions described, indapamide enantiomers were well resolved with a resolution factor (Rs) of at least 2.0 and with retention times of 19.2 and 23.3min, respectively. Linear responses (r>0.999) were observed over the range of 0.05-50μg/mL of indapamide enantiomers, with quantitation limit of 0.05μg/mL. The mean relative standard deviation (RSD) of within-day precision and accuracy of the drug were <10%. The mean extraction efficiency was greater than 86% for each enantiomer. The assay method shows good specificity to indapamide enantiomers, and it could be successfully applied to its pharmacokinetic studies and to therapeutic drug monitoring.
本研究描述了一种精确、准确的立体选择性 HPLC 方法，可用于同时测定大鼠单口服给药后 24 小时内全血中的吲达帕胺对映异构体，以研究其药代动力学。在纤维素三（3,5-二氯苯基氨基甲酸酯）柱（Chiralpak IC）上实现了对映异构体的拆分，检测波长为 240nm，流动相由正己烷和异丙醇（70:30，v/v）组成。使用所描述的色谱条件，吲达帕胺对映异构体得到了很好的分离，分离因子（Rs）至少为 2.0，保留时间分别为 19.2 和 23.3min。吲达帕胺对映异构体在 0.05-50μg/mL 的范围内呈现出良好的线性响应（r>0.999），定量限为 0.05μg/mL。药物日内精密度和准确度的平均相对标准偏差（RSD）<10%。每个对映异构体的平均提取效率均大于 86%。该测定方法对吲达帕胺对映异构体具有良好的特异性，可成功应用于其药代动力学研究和治疗药物监测。
