不同方法测定口服五维赖氨酸葡萄糖中盐酸赖氨酸含量的研究  

Comparison of different methods for the determination of lysine hydrochloride in oral five vitamins lysine and glucose

作　　者：何虹 刘庄蔚 蒋洁 谭菊英 HE Hong;LIU Zhuang-wei;JIANG Jie;TAN Ju-ying(Guangxi Institute for Drug Control,Nanning 530021,China)

机构地区：[1]广西壮族自治区药品检验研究院,广西南宁530021

出　　处：《化学工程师》2024年第5期20-25,共6页Chemical Engineer

基　　金：2022年国家药品抽检计划项目(国药监药管[2022]1号,序号25);广西药品监督管理局科研计划项目(桂药监科[2022]-037号(直属))。

摘　　要：目的分别建立氨基酸分析仪测定法、高效液相色谱测定法测定口服五维赖氨酸葡萄糖中盐酸赖氨酸的含量,比较两种分析方法的适用性。方法氨基酸分析仪法:钠系统,程序洗脱,LCAK06/Na色谱柱分离,茚三酮溶液衍生显色,测定波长570nm;高效液相色谱法:以Alltima-C_(18)(250mm×4.6mm,5μm)为色谱柱,以5mmol·L^(-1)庚烷磺酸钠溶液(用20%H_(3)PO_(4)溶液调节pH值为2.5)为流动相A,乙腈为流动相B,梯度洗脱,流速为1mL·min^(-1),柱温为40℃,检测波长200nm,进样量为20μL。结果两种方法测定96批口服五维赖氨酸葡萄糖中盐酸赖氨酸的含量,结果经T检验统计分析存在显著性差异(t=4.413,P<0.001)。结论氨基酸分析仪法与高效液相色谱法比较,更适用于口服五维葡萄糖赖氨酸颗粒中盐酸赖氨酸含量的测定,且所建立的方法简单、快捷、专属性好,可以用于本品的质量控制。OBJECTIVE The content of lysine hydrochloride in oral five dimension lysine glucose was determined by amino acid analyzer and HPLC,and the applicability of the two methods was compared.METHODS The eluted with an amino acid analyzer sodium system,separated by LCAK06/Na column,and colorimetrically derived from ninhydrin solution,and the lysine chromatographic peaks was measured at a wavelength of 570nm;HPLC method with Multi-wavelength.The determination was performed on Alltima-C_(18) column with 5mmol·L^(-1) sodium heptanesulfonate solution(pH 2.5 was adjusted by 20%phosphoric acid solution)as mobile phase A,acetonitrile as mobile phase B(gradient elution),at the flow rate of 1.0mL·min^(-1).The column temperature was set at 40℃,The sample size was 20μL.RESULTS The content of lysine hydrochloride in 96 banches of oral five vitamins lysine and glucose was determined by two methods,and there was significant difference between amino acid analyzer method and HPLC method(t=4.413,p<0.001).CONCLUSION Using an amino acid analyzer to determine the content of lysine hydrochloride in oral five vitamins lysine and glucose is more accurate than using high-performance liquid chromatography.The method is simple,convenient,and more applicable,which can be used for the quality control this product.

关 键 词：氨基酸分析仪 口服五维赖氨酸葡萄糖 盐酸赖氨酸 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学] O657.72[医药卫生—药学]