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示差折光-HPLC法测定舒血宁注射液中山梨醇的含量

高亮 周永妍 孙胜斌 姜国志 武晓媛 王文鹏

河北工业科技2017,Vol.34Issue(5):324-327,4.
河北工业科技2017,Vol.34Issue(5):324-327,4.DOI:10.7535/hbgykj.2017yx05003

示差折光-HPLC法测定舒血宁注射液中山梨醇的含量

Determination of sorbitol in Shuxuening injection by HPLC with refractive index detector

高亮 1周永妍 1孙胜斌 1姜国志 2武晓媛 2王文鹏1

作者信息

  • 1. 神威药业集团有限公司,河北石家庄 051430
  • 2. 中药注射剂新药技术开发国家地方联合工程实验室,河北石家庄 051430
  • 折叠

摘要

Abstract

The existing sorbitol content detection method in the determination of the sorbitol content in Shuxuening injection has some problems such as that the specificity is not strong,the operation is complicate and so on.Aiming at the problems,the refractive index-HPLC method for the determination of sorbitol content in Shuxuening injection is established.The content of sorbitol in Shuxuening injection is determined on a Carbomix Ca-NP10:8 % (7.8 mm × 300 mm) with a mobile phase of water at a flow rate of 0.5 mL/min.Column temperature is 80 ℃ and refractive index detector of HPLCis used.The results show that a nice linearity is obtained between the sorbitol mass concentration of 0.2~2.0 mg/mL (r2 =0.999 5) and peak area,and the average recovery (n=9) is of 99.9%.The method is convenient,selective and reproducible,and can be used for quality control of Shuxuening capsules.

关键词

色谱分析/山梨醇/舒血宁注射液/HPLC/示差折光

Key words

chromatographic analysis/sorbitol/Shuxuening injection/HPLC/refractive index detector

分类

医药卫生

引用本文复制引用

高亮,周永妍,孙胜斌,姜国志,武晓媛,王文鹏..示差折光-HPLC法测定舒血宁注射液中山梨醇的含量[J].河北工业科技,2017,34(5):324-327,4.

基金项目

国家“重大新药创制”科技重大专项(2014ZX09201022-004) (2014ZX09201022-004)

河北工业科技

OACSTPCD

1008-1534

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