文章摘要
周远华.HPLC法同时测定五维赖氨酸口服溶液中4种水溶性主成分的含量[J].中国药品标准,2023,24(1):
HPLC法同时测定五维赖氨酸口服溶液中4种水溶性主成分的含量
Simultaneous Determination of Four Water-soluble Active Ingredients in Five Vitamins and Lysine Hydrochloride Oral Solution by HPLC
投稿时间:2022-01-30  修订日期:2023-01-31
DOI:
中文关键词: 五维赖氨酸口服液  水溶性主成分  高效液相色谱法  同时测定  含量
英文关键词: Five Vitamins and Lysine Hydrochloride Oral Solution  water-soluble active ingredients  HPLC  simultaneous determination  content
基金项目:
作者单位E-mail
周远华* 广州市药品检验所 yhchow@163.com 
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中文摘要:
      目的:建立直接同时测定五维赖氨酸口服溶液中盐酸赖氨酸和三种水溶性维生素含量的RP-HPLC法。方法:采用Phenomenex Gemini C18 100A(250×4.6mm,5μm)色谱柱,以0.03mol·L-1磷酸二氢铵溶液(pH3.0)-甲醇(98:2)为流动相,检测波长为205nm,流速1.0mL·min-1。结果:盐酸赖氨酸、维生素C、维生素B6和烟酰胺分别在30.56~488.9μg·mL-1(r=1.0000)、24.86~397.8μg·mL-1(r=0.9998)、1.018~16.29μg·mL-1(r=1.000 0)、10.72~171.5μg·mL-1(r=0.9990)范围内与峰面积呈良好的线性关系;定量限分别为10.39ng、0.4661ng、0.09279ng、0.1362ng;平均回收率分别为100.6%、98.5%、98.0%、99.2%,RSD分别为0.1%、0.1%、0.1%、0.03%。结论:本实验建立的分析方法能够同时准确测定五维赖氨酸口服溶液中的4种水溶性主成分,方法操作简单、专属性强、灵敏度高,可用于控制五维赖氨酸口服溶液的质量。
英文摘要:
      Objective: To establish an RP-HPLC method for simultaneous direct determination of lysine hydrochloride and three water-soluble vitamins in Five Vitamins and Lysine Hydrochloride Oral Solution. Methods: The method was established by using Phenomenex Gemini C18 100A column(250×4.6mm, 5μm). The mobile phase was 0.03 mL·min-1 ammonium dihydrogen phosphate solution(pH3.0)-methanol(98:2) at a flow rate of 1.0mL·min-1. The detective wavelength was 205 nm. Results: The calibration curve of lysine hydrochloride, vitamin C, vitamin B6 and nicotinamide were in good linearity over the range of 30.56~488.9μg·mL-1(r=1.0000), 24.86~397.8μg·mL-1(r=0.9998), 1.018~16.29μg·mL-1(r=1.000 0), 10.72~171.5μg·mL-1(r=0.9990), respectively. The limit of quantification were 10.39ng, 0.4661ng, 0.09279ng, 0.1362ng, respectively. The average recovery were 100.6% with RSD 0.1%, 98.5% with RSD 0.1%, 98.0% with RSD 0.1%, 99.2% with RSD 0.1%, respectively. Conclusion: The proposed HPLC method can determine the four water-soluble active ingredients with specificity and accuracy without prior processing, which can be successfully applied in quality control of Five Vitamins and Lysine Hydrochloride Oral Solution.
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