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目的定量分析人血浆中加替沙星的浓度,研究加替沙星眼用凝胶连续7 d给药后加替沙星在健康男性受试者体内的暴露特点。方法建立人血浆中加替沙星的LC-MS-MS定量分析方法 ,并对该方法的特异性、灵敏度、精密度与准确度、基质效应、回收率、稳定性等进行考察;测定10名男性健康受试者连续7 d滴用加替沙星眼用凝胶后不同时间点血浆样品中加替沙星的浓度。结果 LC-MS/MS定量分析人血浆中加替沙星的线性范围为2~500 ng·m L-1;在5、10、50和400 ng·m L-1浓度水平的准确度(RE)在±15.0%以内,批内精密度(RSD)在1.47%~2.61%之间,批间精密度(RSD)在1.79%~13.1%之间,基质效应、回收率、特异性、稳定性等进行考察均满足要求。受试者连续给药后所有血浆样品中加替沙星的药物浓度均低于定量下限(2 ng·m L-1)。结论本实验建立了灵敏、准确的加替沙星定量分析方法 ,受试者连续7 d滴用加替沙星眼用凝胶后在所有血浆样品中加替沙星的药物浓度均低于定量下限(2 ng·m L-1)。
Objective To quantitatively analyze the concentration of gatifloxacin in human plasma and investigate the exposure characteristics of gatifloxacin in healthy male subjects after administration of gatifloxacin ocular gel for 7 consecutive days. Methods The method for the quantitative analysis of gatifloxacin in human plasma was established. The specificity, sensitivity, precision and accuracy, matrix effect, recovery rate and stability of the method were investigated. The concentrations of gatifloxacin in plasma samples from male healthy volunteers for 7 consecutive days after dripping with gatifloxacin eyelid gel at different time points. Results LC-MS / MS quantitative analysis of human plasma gatifloxacin linear range of 2 ~ 500 ng · m L-1; 5,10,50 and 400 ng · m L-1 level of accuracy (RE ) Was within ± 15.0%, intra-assay RSD was between 1.47% and 2.61%, inter-assay precision was between 1.79% and 13.1%, matrix effect, recovery, specificity and stability To study and so on to meet the requirements. The drug concentrations of gatifloxacin in all plasma samples after the continuous administration of the subject were below the lower limit of quantitation (2 ng · m L -1). Conclusions This study established a sensitive and accurate method for the quantitative analysis of gatifloxacin. The drug concentrations of gatifloxacin in all plasma samples after 7 consecutive days of drip with gatifloxacin eye gel were lower than those of gatifloxacin Lower limit (2 ng · m L-1).