非那雄胺片剂的HPLC-MS法人体生物等效性研究  

Bioequivalence Study of Finasteride Tablets in Human Plasma by HPLC-MS

作　　者：刘浩[1] 徐建平[2] 高鸿彬[3] 崔英[1] 相秉仁[2] 

机构地区：[1]广东食品药品职业学院药学系,广东广州510520 [2]中国药科大学分析测试中心,江苏南京210009 [3]第二军医大学附属长海医院药学部,上海200433

出　　处：《今日药学》2012年第2期67-70,共4页Pharmacy Today

基　　金：广东省自然科学基金(编号:10151052005000003);广东省医学科研基金(编号:B2009043;B2010055)

摘　　要：目的建立血浆中非那雄胺的反相HPLC-MS测定法,研究其生物等效性。方法采用C18色谱柱,流动相:甲醇-10 mmol/L醋酸铵水溶液(70∶30,v/v);流速:1.0 ml/min;离子化方式:气动辅助电喷雾离子化(ESI);离子检测方式:选择性离子检测(SIM);非那吡啶作为内标,血浆样品用乙酸乙酯提取。结果血浆中杂质不干扰样品的测定,标准曲线线性范围为0.5～200 ng/ml,线性关系良好;高、中、低3种浓度的日间和日内变异均小于10.0%;绝对回收率为84.71%～89.05%;符合生物样品分析要求。结论 20名健康受试者口服非那雄胺2种制剂,对参数Cmax、AUC0-τ进行方差分析,双单侧t检验,Tmax非参数法进行检验,表明所研究的非那雄胺片以非那雄胺计生物等效。To established a new RP-HPLC-MS method for the determination of finasteride concentration in plasma, and to investigate the bioequivalence of finasteride. Methods C：s Column was employed. The mobile phase was consisted of methanol-NH4 Acsolution （10 mmol/L） （70：30）, the flow rate was 1 ml/min, Electrospray ionization （ESI） and selected ion monitoring （SIM） were used; phenazopyridine was used as internal standard. Results The established method was linear in the range of 0.5 - 200 ng/ml, the RSD of precision was 〈 10.0%, and the absolute recovery was 84.71% - 89.05%, which is suitable for the analysis of biological sample. Conclusion The comparison of Cmax, AUC0-t-test, and Tmax data obtained from 20 heahhy volunteers given reference and test tablets indicates that the 2 formulations were bioequivalent.

关 键 词：HPLC-MS 非那雄胺 血药 生物等效性 

分 类 号：R915[医药卫生—微生物与生化药学]