RP-HPLC法测定人唾液中依诺沙星浓度

RP - HPLC Determination of Enoxacin in Saliva

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: A RP - HPLC method has been developed for the determination of enoxacin in human saliva. Methods: With pipemidic acid as the internai Standard, the saliva concentration of enoxacin was assayed on a Shim - pack CLC - ODS column, the mobile phase was methanol -0. 1mol·L-1 citric acid (28:72 ) at a flow rate of 1. 0 mL · min-1. The detection wavelength was 266 nm. The pharmacokinetic parameters of enoxacin cap-sules after a single oral dose of 400 mg in 9 normai volunteers were calculated according to saliva concentration. Results: Enoxacin was satisfactorily separated from the internai Standard and other substances in saliva. The Standard curve was linear (r =0. 999 6) within the range of 0.1 - 10. 0 μg · mL-1 for enoxacin, the mean recovery was 99. 81 % , the within - day precision RSD was 2. 8 % and the inter - day precision RSD was 4. 8% . T1/2ke Tmax and CL · F-1 of enoxacin in human were 4. 05 h, 1. 54 h and 31. 25 L · h-1 respectively, which were similar to those calculated according to plasma concentration. Conclusion: This method is simple, quick and specific, and suitable for saliva concentration detection and pharmacokinetic study of enoxacin.