HPLC法测定复方锌铁钙口服溶液中维生素B_(2)有关物质  

Determination of related substances of vitamin B_(2) in compound zinc,iron and calcium oral solution by HPLC

作　　者：李琦 李晓燕 刘雁鸣 舒森 李钰鑫 LI Qi;LI Xiaoyan;LIU Yanming;SHU Sen;LI Yuxin(Hunan Institute for Drug Control,Changsha 410001,China;Key Laboratory of Pharmaceutical Excipients Engineering Technology Research,National Medical Products Administration,Changsha 410001,China;Hunan Engineering Technology Research Center for Drug Quality Evaluation,Changsha 410001,China;Hunan Drug Inspection Center,Changsha 410001,China;Yueyang Hudex Pharmaceuticals Ltd.,Yueyang 414022,Hunan Province,China)

机构地区：[1]湖南省药品检验检测研究院,长沙410001 [2]国家药品监督管理局药用辅料工程技术研究重点实验室,长沙410001 [3]湖南省药品质量评价工程技术研究中心,长沙410001 [4]湖南省药品审核查验中心,长沙410001 [5]岳阳新华达制药有限公司,湖南岳阳414022

出　　处：《药学前沿》2025年第2期236-242,共7页China Pharmacist

基　　金：湖南省自然科学基金科药联合基金项目(2022JJ80009)。

摘　　要：目的建立复方锌铁钙口服溶液中维生素B_(2)有关物质测定方法。方法色谱柱为Ultimate XB-C18柱(250 mm×4.6 mm,5μm),流动相为1%磷酸溶液(三乙胺调pH至3.5)-乙腈,梯度洗脱,检测波长为260 nm,流速为1.0 mL/min,柱温为40℃,进样量为20μL。结果该法对维生素B_(2)及其降解杂质光色素、光黄素均能有效分离;维生素B_(2)、光黄素与光色素的线性范围分别为0.119~3.594μg/mL(r=1.0000)、0.115~3.479μg/mL(r=1.0000)、0.114~3.435μg/mL(r=0.9999),光黄素和光色素的校正因子分别为0.7与1.0。结论该法专属性强、操作简便、灵敏度高、重复性好,能有效测定复方锌铁钙口服溶液中维生素B_(2)的降解杂质,为提升药品质量、降低用药风险提供技术支撑。Objective To establish a method for the determination of related substances of vitamin B_(2) in compound zinc,iron and calcium oral solution.Methods The chromatographic column was Ultimate XB-C18 column(250 mm×4.6 mm,5μm).The mobile phase was 1% phosphoric acid solution(with pH of triethylamine adjusted to 3.5)and acetonitrile with gradient elution.The detection wavelength was 260 nm,the flow rate was 1.0 mL/min,the column temperature was 40℃,and the injection volume was 20μL.Results This method could effectively separate vitamin B_(2) and its degraded impurities,lumichrome and lumiflavin.The linear range was 0.119-3.594μg/mL for vitamin B_(2)(r=1.0000),0.115-3.479μg/mL for lumichrome(r=1.0000),and 0.114-3.435μg/mL for lumiflavin(r=0.9999).The correction factors of lumiflavin and lumichrome were 0.7 and 1.0 respectively.Conclusion This method has strong specificity,simple operation,high sensitivity and good repeatability,can effectively determine the degradation impurities of vitamin B_(2) in compound zinc,iron and calcium oral solution,and provide technical support for improving drug quality and reducing medication risks.

关 键 词：复方锌铁钙口服溶液 维生素B_(2) 有关物质 高效液相色谱法 

分 类 号：R927.2[医药卫生—药学]