CAJ | 학술논문

目的建立HPLC-UV法测定人血浆中罗红霉素的方法,并探讨罗红霉素的药代动力学和生物等效性.方法采用Diamonsil C18柱(150 mm×4.6 mm,5 μm),流动相为乙腈∶0.01 mol磷酸二氢铵=39∶61(v/v),流速1 mL/min;以卡马西平为内标,检测波长为210 nm.血浆样品用正己烷(含5%的异丙醇)液-液萃取后经C18分离.结果罗红霉素在0.25～16.0 mg/L线性关系良好,r=0.999,最低检测限为0.25 mg/L.萃取回收率>70%,方法回收率99.8%～110.5%, 批内、批间精密度均<15%.结论 HPLC-UV方法结果准确、灵敏度高,适用于罗红霉素药代动力学和生物等效性研究.
목적 건립HPLC-UV법측정인혈장중라홍매소적방법,병탐토라홍매소적약대동역학화생물등효성.방법 채용Diamonsil C18주(150 mm×4.6 mm,5 μm),류동상위을정∶0.01 mol린산이경안=39∶61(v/v),류속1 mL/min;이잡마서평위내표,검측파장위210 nm.혈장양품용정기완(함5%적이병순)액-액췌취후경C18분리.결과 라홍매소재0.25～16.0 mg/L선성관계량호,r=0.999,최저검측한위0.25 mg/L.췌취회수솔>70%,방법회수솔99.8%～110.5%, 비내、비간정밀도균<15%.결론 HPLC-UV방법결과준학、령민도고,괄용우라홍매소약대동역학화생물등효성연구.
Objective To establish a HPLC-UV method for the determination of roxithromycin in the human plasma and to explore the pharmacokinetics and bioequivalence of roxithromycin．Methods　The analytes were determined by HPLC-UV method using C18 column(150 mm×4.6 mm，5 μm)，Roxithromycin was separated on a C18 column with a mobile phase consisting of acetonitrile:0.01 mol ammonium dihydrogen phosphate(39∶61,v/v),and the flow rate was 1 mL/min.Carbamazepine was used as the internal standard and the wavelength was detected at 210 nm.Roxithromycin was extracted from the plasma sample with N-hexane(including 5% dehydrated alcohol).Results The calibration curve was 1inear within 0.25～16.0 mg/L(r=0.999)．The 1imit of quantitation was 0.25 mg/L.The extraction recovery was>70% and the method recovery was 99.8%～110.5% ．The relative standard deviations for the intra-day and inter-day were<15%.Conclusion The method is HPLC-UV，accurate，rapid and suitable for the pharmacokinetics and bioequiavai1ability study of roxithromycin.