化学工程师2024,Vol.38Issue(5) :20-25.DOI:10.16247/j.cnki.23-1171/tq.20240520

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

何虹 刘庄蔚 蒋洁 谭菊英
化学工程师2024,Vol.38Issue(5) :20-25.DOI:10.16247/j.cnki.23-1171/tq.20240520

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

何虹 1刘庄蔚 1蒋洁 1谭菊英1
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作者信息

  • 1. 广西壮族自治区药品检验研究院,广西 南宁 530021
  • 折叠

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-C18(250mm×4.6mm,5μm)为色谱柱,以5mmol·L-1 庚烷磺酸钠溶液(用 20%H3PO4 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.

Abstract

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-C18 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).C ONCLUSION 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

Key words

amino acid analyzer/oral five vitamins lysine and glucose/lysine hydrochloride/HPLC

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基金项目

国家药品抽检计划(2022)(国药监药管[2022]1号)

国家药品抽检计划(2022)(25)

广西药品监督管理局科研项目(桂药监科[2022]-037号直属)

出版年

2024
化学工程师
黑龙江省化工研究院

化学工程师

CSTPCD
影响因子:0.243
ISSN:1002-1124
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