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目的建立乳酸氟罗沙星分散片人体血药浓度的HPLC测定法,研究其药动学。方法血浆样品加入内标,用二氯甲烷提取,HPLC进行分析。色谱柱为HypersiLODS2,流动相为甲醇-10mmol/L的磷酸二氢钠-5mmol/L四丁基溴化铵溶液(磷酸调PH3.0,1:1)(35:65),内标为加替沙星。结果在51.31～3284.00ng/ml内氟罗沙星与内标峰面积的比值与浓度的线性关系良好。批内RSD<6.7%,批间RSD<4.5%;提取回收率为96.29%～98.98%。乳酸氟罗沙星分散片(以氟罗沙星计)的消除半衰期为(14.241.26)h;峰质量浓度为(2307.80419.83)ng/mL;达峰时间为(0.70.1)h。结论本试验所建立的HPLC方法简便、快速、灵敏,可用于乳酸氟罗沙星分散片的人体动力学研究。
OBJECTIVE To establish a HPLC method for the determination of fleroxacin lactate dispersible tablets in human plasma and study its pharmacokinetics. Methods Plasma samples were spiked with internal standard, extracted with dichloromethane and analyzed by HPLC. The column was Hypersi LODS2 and the mobile phase consisted of methanol-10 mmol / L sodium dihydrogen phosphate-5 mmol / L tetrabutylammonium bromide solution (phosphoric acid, pH3.0,1: 1) Tishaxin. Results The linear relationship between the concentration of fleroxacin and the internal standard peak area was good at 51.31 ~ 3284.00ng / ml. Intra-assay RSD <6.7%, inter-assay RSD <4.5%; extraction recovery 96.29% ~ 98.98%. The elimination half-life of fleroxacin lactate dispersible tablets (calculated as fleroxacin) was (14.241.26) h; the peak mass concentration was (2307.80419.83) ng / mL; the peak time was (0.70.1) h. Conclusion The HPLC method established in this study is simple, rapid and sensitive and can be used to study human kinetics of fleroxacin lactate dispersible tablets.