高效液相色谱法测定注射用法罗培南在健康人血浆和尿中的浓度

目的:建立测定人血浆和尿中注射用法罗培南浓度的高效液相色谱(HPLC)法。方法:血浆样品经10%三氯醋酸沉淀蛋白,尿样直接稀释,以替硝唑为内标,采用乙腈:0.05 mol·L~(-1)磷酸二氢钾缓冲液(pH 3.5,16:84,V:V)为流动相,经Zorbax XDB-C_8柱分离,318 nm波长检测。结果:法罗培南的血浆样品和尿样线性范围分别为0.1～50 mg·L~(-1)和0.5～250 mg·L~(-1),提取回收率分别为51.2%～54.9%和99.6%～104%,日内、日间精密度(RSD)均低于9.14%。结论:本方法准确性好、操作简单,可满足药动学研究的要求。

Determination of faropenem for injection in human plasma and urine by high performance liquid chromatography

AIM:To develop a HPLC method for the determination of faropenem for injection in human plasma and urine.METHODS:Plasma was precipitated with 10% trichloroacetic acid.Using tinidazole as internal standard,the analysis was conducted with a Zorbax XDB-C_8 column with acetonitrile -0.05 mol·L~(-1) monopotassium phosphate(pH 3.5,16:84,V:V)as mobile phase.The detection wavelengh was set at 318 nm.RESULTS:The calibration curves of faropenem in plasma and urine samples were linear over the range of 0.1-50 mg·L~(-1)and 0.5-250 mg·L~(-1)respectively.The absolute recoveries were 51.2%-54.9% in plasma and 99.6%-104% in urine.The RSD of intra-day and inter-day were all less than 9.14%. CONCLUSION:The method is accurate and simple in the determination of faropenem for pharmacokinetics.