中国药房2013，Vol.24Issue(10)：910-913,4.DOI:10.6039/j.issn.1001-0408.2013.10.17
LC-MS/MS法测定氨氯地平血药浓度及其片剂的生物等效性研究
Determination of Amlodipine Concentration in Human Plasma by LC-MS/MS Method and Bioequivalence Study of Its Tablets
张丽娜 1刘曼 1杨漫 1杜爱华 1张娅喃 1张丹 1韩静 1王晓琳 1刘会臣1
作者信息
摘要
Abstract
OBJECTIVE: To develop method for the determination of amlodipine in human plasma, and to evaluate bioequivalence of 2 kinds of Amlodipine besylate tables in healthy volunteers. METHODS: After liquid-liquid extraction, the samples were separated on Zorbax SB-C18 Narrow Bore column with mobile phase consisted of methanol-10 mmol/L ammonium acetate (90:10, V/V) at the flow rate of 0.3 ml/min. Detection was carried out by electrospray positive ionization mass spectrometry in type API3200 multiple reaction monitoring (MRM) mode. The MRM transitions of mlz 409.2→-m/z 238.2 and mlz 256.2→m/z 167.3 were used to quantify amlodipine and diphenhydramine (I.S.), respectively. The bioequivalence of test preparation and reference preparation of Amlodipine besylate tablets in 24 healthy volunteers after oral administration were investigated in a randomized, two-periods cross-over study. RESULTS: Amlodipine and I.S. were eluted at 2.79 min and 2.43 min, respectively. The linear range of amlodipine were 0.10-10.0 ng/ml (r=0.999 7) with the lowest quantitation limit of 0.10 ng/ml. Intra-day and inter-day RSDs were both less than 15% ; relative errors (RE) were within ± 15%. The mean extraction recovery was (84.7 ± 5.5)% , and the mean matrix effect factor was (76.5±8.4)%. The relative bioavailability of test preparation to reference preparation was (105.8±20.9)% according to AUC0-120 h. CONCLUSIONS: The method is rapid, sensitive, selective and reproducible, and it is suitable for the determination of amlodipine in human plasma and bioequivalence study of Amlodipine besylate tablets in healthy volunteers.Two preparations are bioequivalent.关键词
氨氯地平/高效液相色谱串联质谱法/生物等效性Key words
Amlodipine/ LC-MS/MS/ Bioequivalence分类
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张丽娜,刘曼,杨漫,杜爱华,张娅喃,张丹,韩静,王晓琳,刘会臣..LC-MS/MS法测定氨氯地平血药浓度及其片剂的生物等效性研究[J].中国药房,2013,24(10):910-913,4.
