反相高效液相色谱法测定血浆中的帕珠沙星

Determination of pazufloxacin in human plasma by RP-HPLC

目的:建立反相高效液相色谱法测定人血浆中帕珠沙星浓度,用于帕珠沙星人体药动学研究.方法:采用YMC C18(150 mm×4.6 mm,5 μm)色谱柱,柱温为35℃,流动相为乙腈-0.025 mol·L-1醋酸钠(醋酸调pH 2.6)(13:87),流速为1 mL·min-1.以盐酸芦氟沙星为内标,检测波长249 nm.结果:标准曲线线性范围78.125～2 000μg·mL-1;萃取回收率66.76%～72.76%;方法回收率97.85%～110.9%;日内RSD在5.1%～9.9%;日间RSD在4.8%～6.2%.结论:本方法快速、灵敏、准确、简便,适用于帕珠沙星血药浓度测定及药动学研究.

Objective：To develop a RP-HPLC method to determine the concentration of pazufloxacin in human plasma. Methods： The plasma sample was extracted with 3 mL dichloromethane （C. P ）, and subsequently quantified by a HPLC, which was equipped with a YMC C18 column （150 mm × 4.6 mm, 5 μm） with a column temperature at 35℃ and a mobile phase consisted of CH3 CN-0.025 mol·L^-1 NaAc （pH=2.6 adjusted with HAc） （13：87） with a flow rate of 1 mL·min^-1 . The detection wavelength was set at 249 nm. Rufloxacin Hydrochloride （RH） was used as an internal standard. Results：The linearity of calibrated curves was in the range of 0.078 1 - 40.0mg·L^-1. Other quantitative outcomes were shown as the detection limit of 78. 125 ng·L^-1 ; the extraction recovery of 66.76%-72.76% ; the methodological recovery of 97.85% -110.94 % ; within-day RSD of 5.1% - 9.9 % and among-day RSD of 4.8 % - 6.2 %. Conclusion： The sensitive, accurate and easily manipulated assay offered a satisfactory tool in the investigation of the pharmacokinetics and relative bioavailability of pazufloxacin.