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目的:建立测定人唾液中依诺沙星浓度的RP-HPLC法。方法:采用Shim-pack CLC-ODS柱,以甲醇-0.1 mol·L~(-1)柠檬酸(28:72)为流动相,吡哌酸为内标;检测波长为266nm;流速1.0mL·min~(-1) ;柱温为室温;进样量:20μL。根据唾液药物浓度求算9名健康志愿者单剂量口服依诺沙星胶囊的药动学参数。结果:依诺沙星与样品中杂质以及内标分离完全;在0.1～10.0μg·mL~(-1)范围内,依诺沙星和内标峰高比与其浓度线性关系良好(r=0.999 6);样品平均回收率为99.81％;日内RSD=2.8％,日间RSD=4.8％。依诺沙星在人体内的T_(1/2ke),Tin_(max)和CL·F~(-1)分别为4.05h,1.54h,31.25 L·h~(-1),与由血药浓度求算的药动学参数接近。结论:该法简便、快速、专一性强,适用于依诺沙星唾液药物浓度测定及药动学研究之用。
Objective: To establish a RP-HPLC method for the determination of enrofloxacin in human saliva. METHODS: Shim-pack CLC-ODS column was used with methanol-0.1 mol·L -1 citric acid (28:72) as the mobile phase and pipemidic acid as the internal standard. The detection wavelength was 266 nm and the flow rate was 1.0 mL · min ~ (-1); column temperature was room temperature; injection volume: 20μL. The pharmacokinetic parameters of enoxacin capsules in a single dose of 9 healthy volunteers were calculated according to the concentration of saliva drug. Results: Enoxacin was completely separated from the impurities in the sample and the internal standard. The linear relationship between enoxacin and internal standard peak height was good (r = 0.999) in the range of 0.1-10.0 μg · mL -1 6). The average recovery was 99.81%. The intraday RSD was 2.8% and the interday RSD was 4.8%. Enoxacin in human body T_ (1 / 2ke), Tin_ (max) and CL · F -1 (4.05h, 1.54h, 31.25 L · h -1, respectively, Concentration calculated pharmacokinetic parameters close. Conclusion: The method is simple, rapid, specific and suitable for the determination of enoxacin saliva drug concentration and pharmacokinetic studies.