HPLC法测定米格列奈钙原料药含量及有关物质  

HPLC determination of the concentrations of mitiglinide and its related substances

作　　者：张斐[1] 李小敏[1] 许向阳[1] 骆宏鹏[1] 

机构地区：[1]江苏先声药物研究有限公司,南京210042

出　　处：《中国新药杂志》2007年第6期470-471,共2页Chinese Journal of New Drugs

摘　　要：目的：用HPLC法测定米格列奈钙原料药的含量及其有关物质，为米格列奈钙原料药的含量和有关物质测定提供检测方法，制定质控标准。方法：用十八烷基硅烷键合硅胶为填充剂，以0．1mol·L^-1磷酸二氢铵缓冲盐（磷酸调节pH=3．0）-甲醇-乙腈（25：35：40）作为流动相；检测波长为210nm；柱温30℃；流速约为1．0mL·min^-1。结果：主峰能与相邻杂质峰较好分离，米格列奈钙的浓度在14～350μg·mL^-1范围内线性关系良好，相关系数为0．9993。结论：该法简便、准确、专属性好，可以用于米格列奈钙原料药的含量及有关物质的测定。Objective： To establish a HPLC method for the determination of concentrations of mitiglinide and its related substances. Methods： The HPLC condition was consisted of a C18 column （250 mm×4.6 mm, 5μm） with a column temperature at 30 ℃, an eluate of methanol： acetonitrile： phosphate buffer （0. 1 mol·L^-1 ammonium dihydrogen phosphate, pH = 3.0, adjusted with phosphoric acid） （ 25 ： 35 ： 40, v/v/v） with a flow rate of 1.0 mL·min^-1 and detection at 210 nm. Results ： Mitiglinide calcium was completely separated from impurities. The calibrated linear curve of mitiglinide concentration was within 14～350μg·mL^-1 with the correlation coefficient of 0. 999 3. Conclusion ： This accurate and reliable HPLC method is applicable for the quality control of mitiglinide and its related substances.

关 键 词：高效液相色谱法 米格列奈钙 含量测定 有关物质 

分 类 号：R927.2[医药卫生—药学]