摘要
目的建立测定人血浆中阿莫西林质量浓度的高效液相色谱-质谱(HPLC-MS/MS)联用检测方法,并用于生物等效性研究。方法以阿莫西林-d4为内标,血浆样品经甲醇沉淀后,经HPLC-MS/MS分析。色谱柱为ZORBAX SB-Aq (150 mm×4.6 mm,3.5μm);流动相为甲醇-2 mL·L^(-1)甲酸溶液(40∶60);流速为0.6 mL·min^(-1)。采用电喷雾离子源(ESI),多重反应选择离子监测(MRM)负离子模式,阿莫西林和阿莫西林-d4的定量离子对分别为m/z 364→223和m/z 368→227。结果阿莫西林血药质量浓度在0.088 57～39.370 00μg·mL^(-1)范围内线性关系良好,选择性、准确度、精密度、提取回收率、基质效应和稳定性等均符合要求。结论该方法简单、快速、灵敏、准确,可用于阿莫西林血药质量浓度的检测及生物等效性研究。
Objective To establish an high performance liquid chromatography-mass spectrum/mass spectrum (HPLC-MS/MS) method for the determination of amoxicillin in human plasma,and to study its bioequivalence. Methods Plasma samples were precipitated with methanol and determined by HPLC-MS/MS using amoxicillin-d4 as an internal standard.The separation was carried out on a ZORBAX SB-Aq column (150 mm×4.6 mm,3.5 μm) with a mobile phase of methanol-2 mL ·L^-1 formic acid (40∶60) in a flow rate of 0.6 mL·min^-1 .Electrospray ionization (ESI) was performed in a MRM negative mode using target ions at m / z 364→223 (amoxicillin) and m / z 368→227 (amoxicillin-d4),respectively. Results The calibration curve was linear within the range of 0.088 57 -39.370 00 μg·mL -1 with good selectivity,accuracy,precision,recovery,matrix effect and stability. Conclusion The developed method is simple,fast,sensitive and accurate,and it can be applied for the determination and bioequivalence study of amoxicillin.
作者
陈冠华
江羽
雷后亮
CHEN Guanhua;JIANG Yu;LEI Houliang(Zhejiang Jinhua CONBA Bio-Pharm Limited Company,Jinhua 321016,China;Tikun Pharma Technology (Hangzhou) Limited Company,Hangzhou 310000,China)
出处
《西北药学杂志》
CAS
2019年第3期327-331,共5页
Northwest Pharmaceutical Journal
