RP-HPLC法测定甲硫氨酸维B_1注射液的含量  

HPLC determination of methionine and vitamin B_1 injection

作　　者：张斐[1] 李小敏[1] 刘春晖[1] 许向阳[1] 

机构地区：[1]江苏先声药物研究有限公司,南京210042

出　　处：《药学与临床研究》2007年第1期78-80,共3页Pharmaceutical and Clinical Research

摘　　要：目的：用HPLC法同时测定复方甲硫氨酸维B1注射液中甲硫氨酸和维生素B1的含量，为复方甲硫氨酸维B1注射液的含量测定提供检测方法，制定质控标准。方法：用十八烷基键合硅胶为填充剂；0．005mol·L^-1庚烷磺酸钠溶液（pH=3．0）与乙腈为流动相，梯度洗脱；检测波长为210nm；柱温30℃；流速约为1．0mL·min^-1。结果：甲硫氨酸与维生素B1分别能与相邻杂质峰较好分离，甲硫氨酸的浓度在0．10～2．10mg·mL^-1范围内线性相关性良好，维生素B1的浓度在0．011～0．21mg·mL^-1范围内线性相关性良好。结论：该法简便、准确、专属性好，可以用于甲硫氨酸维B1注射液的含量测定。Objective： To establish the HPLC method for the determination of methionine and vitamin B1 in metnionine-vitamin B1 injectiono Methods： The HPLC system consisted of a C18 chromatographic column and a mixture of acetonitrile and 0.005 mol·L^-1 heptane sulfonic acid sodium solution （ pH = 3.0） as a mobile phase used for gradient elution. The flow rate was 1.0 mL·min^-1 with a detection wavelength at 210 nm and column temperature 30 ℃. Results： Methionine and vitamin B1 could be completely separated from other impurities. The linear range of methionine was 0.10 - 2.10 mg· mL^-1 and vitamin B1 was 0. 011 - 0.21 mg · mL^-1 respectively. Conclusion： The method was simple, accurate, suitable for the determination of methionine and vitamin B1 in methionine and vitamin B1 injection.

关 键 词：HPLC 甲硫氨酸 维生素B1 

分 类 号：R927.2[医药卫生—药学]