用RP-HPLC法测定人血浆中巴洛沙星浓度并应用于治疗药物监测

Determination of the content of balofloxacin in human plasma by RP-HPLC method and its application in therapeutic drug monitoring

目的：建立巴洛沙星血药浓度的RP-HPLC测定方法，并用于巴洛沙星片剂的药动学参数测定，为临床合理用药提供参考。方法：色谱柱为Diamonsil ODS C18柱（150mm×4．6mm，5μm），流动相为乙腈-水（含0．04mol／L磷酸和0．4％三乙胺，pH=4．5）=23：77，流速为1．0mL／min，柱温35℃，检测波长294nm。内标物为加替沙星。将该方法用于单剂量口服100mg巴洛沙星片的主要药动学参数研究。结果：该方法的线性范围为0．05～5．00μg／mL（r=0．9998），方法的日内及日间RSD〈10％。结论：该方法准确、快速、简便，可为临床评价药物治疗效果提供参考。

Objective：To establish a RP-HPLC method for the determination of the content of balofloxacin in human plasma and study the pharmacokinetics of balofloxacin tablets after a single oral dose of 100 mg in healthy Chinese volunteers. Methods：Diamonsil ODS C18 column （150 mm×4. 6 mm, 5 μm ） was used with the mobile phase consisting of acetonitrile-water （containing 0.04 mol/L H3PO4 and 0.4% triethylamine,pH=4.5） =23 ： 77. The flow rate was 1.0 mL/min. The detection wavelength was 294 nm and gatifloxacin was used as the internal standard. The column temperature was 35 ℃. The method was used to study the pharmacokinetics of balofloxacin in healthy volunteers. Results： The linear range of balofloxacin was 0.05 5.00 μg/mL,r=0. 999 8. The intra-day and inter-day RSDs of balofloxacin samples were less than 10%. The main pharmacokinetic parameters of the study were similar to those reported in the literature. Conclusion： The method is accurate, rapid and convenient for the determination of balofloxacin in human plasma and can be used to study the pharmacokinetics of balofloxacin.