甲钴胺注射液有关物质检验方法研究  

Study on Detection of Related Substances in Mecobalamin Injection

作　　者：任萃文 陆勇 REN Cui-wen;LU Yong(Harbin Medisan Pharmaceutical Co.,Ltd.,Harbin 150025,China)

机构地区：[1]哈尔滨三联药业股份有限公司,黑龙江哈尔滨150025

出　　处：《食品与药品》2023年第6期527-531,共5页Food and Drug

摘　　要：目的 优化甲钴胺注射液有关物质检测方法。方法 在国内外标准方法基础上建立高效液相色谱(HPLC)法测定甲钴胺注射液有关物质。采用Agela Venusil MP C_(18)(4.6 mm×250 mm,5μm)色谱柱,梯度洗脱,流速1.3 ml/min,检测波长:266 nm,柱温:40℃,进样量:10μl。结果 优化后的方法能有效地定量已知杂质和未知杂质。结论 优化后的方法能科学合理地控制产品质量,保证用药安全。Objective To optimize the detection method of related substances in Mecobalamin Injection.Methods On the basis of methods listed in domestic and foreign standards,an HPLC method was established for the determination of related substances in Mecobalamin Injection.An Agela Venusil MP C18(4.6 mm×250 mm,5μm)chromatographic column was used,and gradient elution was adopted.The flow rate of the mobile phase was 1.3 ml/min,the detection wavelength was 266 nm,the column temperature was 40℃,and the injection volume was 10μl.Results The optimized method could effectively quantify known and unknown impurities.Conclusion The optimized method can control product quality scientifically and reasonably and ensure drug safety.

关 键 词：甲钴胺 注射液 有关物质 检验方法 高效液相色谱(HPLC) 

分 类 号：R917[医药卫生—药物分析学]