HPLC法测定注射用赖氨匹林中赖氨酸含量  

Determination of Lysine Content in Injection Aspirin-DL-lysine by HPLC

作　　者：周敏 郑培 ZHOU Min;ZHENG Pei(Hainan Academy of Inspection and Testing,Hainan Haikou 570206,China)

机构地区：[1]海南省检验检测研究院,海南海口570206

出　　处：《广州化工》2024年第7期128-130,共3页GuangZhou Chemical Industry

摘　　要：氨基酸作为营养补充剂在药品注射用剂型中配伍较多,检验方法通常为反向色谱法,本文从色谱柱入手改进,应用正向液相色谱法,结合赖氨酸的理化性质,采用HILIC Amide为填料的色谱柱(250 mm×4.6 mm,5μm),以0.05 mol/L磷酸二氢钾∶乙腈=35∶65为流动相,流速为1.0 mL/min,柱温为30℃,检测波长205 nm,对赖氨酸进行定量分析,建立注射用赖氨匹林中赖氨酸含量的HPLC检测方法。在此色谱条件下,赖氨酸的线性范围为0.102~2.037 mg/mL(r^(2)=1.000),平均回收率(n=9)为99.6%。实验设置考察两个品牌同类型色谱柱的检测结果差异性,RSD值(n=4)不超过2.0%,方法具备耐用性,同时考察同类厂家两个规格的产品按原企业方法和笔者建立方法的检测结果差异性,RSD值(n=4)不超过2.0%,本方法结果准确,简单高效,可用于注射用赖氨匹林的质量控制检测,以期为我国药典相关标准的建立提供参考。Amino acids are commonly used as dietary supplements in injection forms of medicines,the inspection method is usually reverse chromatography.Started with the column improvement,forward liquid chromatography was used,combining the physical and chemical properties of lysine,chromatographic column with HILIC Amide as filler(250 mm×4.6 mm,5μm),the mobile phase was 0.05 mol/L potassium dihydrogen phosphate∶acetonitrile=35∶65,the flow rate was 1.0 mL/min,the column temperature was 30℃,detection wavelength was 205 nm,quantitative analysis of lysine was carried out to establish HPLC method for the determination of lysine in lysine injection.Under this chromatographic condition,the linear range of lysine was 0.102~2.037 mg/mL(r^(2)=1.000),the average recovery rate(n=9)was 99.6%.The experiment was set up to investigate the difference of detection results between two brands of same type chromatographic columns,when RSD(n=4)did not exceed 2.0%,the method was durable,and can investigate the brother manufacturers of two specifications of products according to the original enterprise method and the author s new method detection results difference,when RSD(n=4)did not exceed 2.0%,this method was simple,efficient and accurate,and can provide reference for the quality control of lyserpyrine for injection and the establishment of relevant standards in Chinese pharmacopoeia.

关 键 词：赖氨酸 含量测定 高效液相色谱法 质量控制 

分 类 号：R917[医药卫生—药物分析学]