液质联用法测定盐酸美西律片的含量  

Content Determination of Mexiletine Hydrochloride Tablets by HPLC- MS / MS

作　　者：杨敏 崔艳[2] 吴威[2] 

机构地区：[1]黑龙江省齐齐哈尔市食品药品检验检测中心,黑龙江齐齐哈尔161005 [2]黑龙江省哈尔滨市第一医院,黑龙江哈尔滨100730

出　　处：《中国药业》2017年第2期35-37,共3页China Pharmaceuticals

摘　　要：目的建立测定盐酸美西律片含量的高效液相色谱-质谱联用(HPLC-MS/MS)法。方法采用HPLC-MS/MS仪,色谱柱为Agilent Zorbax SB-C18柱(150 mm×2.1 mm,5μm),以0.1%甲酸乙腈-0.1%甲酸水(30∶70)为流动相,流速为0.2 m L/min,柱温为30℃;以阿替洛尔为内标物,采用电喷雾电离(ESI),正离子模式,多反应监测(MRM)扫描方式。结果盐酸美西律质量浓度在0.627~20.064μg/m L范围内与峰面积线性关系良好(r=0.999 7),定量限为0.5 ng/m L,方法回收率为99.32%,RSD=0.85%(n=9),稳定性良好。结论该方法分析快速,专属性强,灵敏度高,可用于盐酸美西律片的质量控制。Objective To establish an HPLC-MS/MS method for the determination of mexiletine hydrochloride tablets. Methods The LC-MS/MS was used. The samples were carried out on an Agilent Zorbax SB-C18 column（150 mm ＆#215; 2. 1 mm,5 μm）. The mobile phase was composed of 0. 1% formic acid acetonitrile-0. 1% formic acid water（30 ：70）at a flow rate of 0. 2 mL/min. The column temperature was 30 ℃. Atenolol was used as the internal standard. The detection was performed with MRM using electrospray ionization （ESI）. Results A good linearity of mexiletine hydrochloride was obtained in the range of 0. 627-20. 064 μg/mL（ r=0. 999 7） and the limit of quantitation of mexiletine hydrochloride was 0. 5 ng/mL. The recovery rate was 99. 32%（ RSD=0. 85%,n=9）and the sta-bilities were good. Conclusion This method is fast,sufficiently selective and sensitive which provides an analytical basis for the quality control of mexiletine hydrochloride tablets.

关 键 词：盐酸美西律片 含量 高效液相色谱-质谱联用法 质量控制 

分 类 号：R972.2[医药卫生—药品] R927.2[医药卫生—药学]