高效液相色谱法测定血浆中盐酸非那吡啶的浓度  

HPLC determination of phenazopyridine hydrochloride in human plasma of healthy volunteers

作　　者：何海霞[1] 周远大[1] 唐竟[2] 

机构地区：[1]重庆医科大学附属第一医院临床药理研究室,重庆400016 [2]重庆医药工业研究院,重庆400000

出　　处：《药物分析杂志》2006年第4期457-459,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立测定盐酸非那吡啶(PNPD)血药浓度的高效液相色谱法(HPLC)并对健康男性受试者服药后的血药浓度进行测定。方法:采用 HYPERSIL C_(18)柱(5μm,200 mm×5.0 mm),以地西泮(DZP)为内标,乙腈-0.01 mol·L^(-1)磷酸二氢钾溶液(50:50,用磷酸调 pH 至3.5左右)为流动相,流速1.2 mL·min^(-1);在紫外307 nm 波长处检测。结果:PNPD 血药浓度线性范围为2.0～510.0 ng·mL^(-1)(r=0.9998),最低定量浓度为1.0 ng·mL^(-1);高、中、低3种浓度 PNPD 的方法回收率为96.72%～111.7%,萃取回收率为73.21%～103.8%。结论:本法的灵敏度、准确度及回收率均能达到健康受试者血浆药物浓度的测定要求,也可用于临床人体生物等效性的研究。Objective： To establish an HPLC method for the determination of phenazopyridine hydrochloride （PNPD） in human plasma and applied to determine drug plasma concentration in healthy volunteers. Methods： The compounds were separated on a HYPERSIL Cls column （5μm,200 mm ×5.0 mm）. Internal standard was diazepam（DZP）. The mobile phase was composed of acetonitrile-0.01 moL · L^-1 KH2PO4 （50： 50, adjusted to about pH 3.5 by H3PO4） ,the flow rate was 1.2 mL · min^-1. The detection wavelength was UV 307 nm. Results：A good linearity was obtained from 2. 0 to 510. 0 ng·mL^-1 in plasma with a correlation coefficient of 0. 9998. The lowest concentration detected was 1.0 ng · mL^-1. The recoveries of method were from 96. 72% to 111.7% ,and recoveries of extraction were from 73.21% to 103.8%. Conclusion：The method is sensitive,accurate and reproducible. It is an available method for determining drug plasma concentration of healthy volunteers and can be used for clinical bioequialent study of phenazopyridine hydrochloride.

关 键 词：盐酸非那吡啶 血药浓度 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]