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硫辛酸片含量与降解物的高效液相色谱测定研究

叶汝汉 张怡 彭蕾 孙晋红 张嘉颖 张慧影 伍迪科 张萍

分析测试学报2013,Vol.32Issue(7):894-897,4.
分析测试学报2013,Vol.32Issue(7):894-897,4.DOI:10.3969/j.issn.1004-4957.2013.07.021

硫辛酸片含量与降解物的高效液相色谱测定研究

Determination of Thioctic Acid Tablets and Their Degradation Products by HPLC

叶汝汉 1张怡 2彭蕾 1孙晋红 1张嘉颖 1张慧影 1伍迪科 1张萍1

作者信息

  • 1. 广州法尔麦兰药物技术有限公司,广东广州510070
  • 2. 中国广州分析测试中心,广东广州510070
  • 折叠

摘要

Abstract

A high-performance liquid chromatographic (HPLC) method for the determination of relative substances in thioctic acid tablets was developed.The separation of analyte was performed on a Waters XBridge column(5 μm,150 mm × 4.6 mm) with phosphate buffer(pH value was adjusted to 2.5 with phosphoric acid)-acetonitrile-methanol(50 ∶ 45 ∶ 5) as mobile phase,at a flow rate of 1.0 mL/min and an injection volume of 20 μL.The photo-diode array detector(PDA) was set at 220 nm,with full scan range of 200-400 nm.The column temperature was ambient.Under the above chromatographic conditions,the calibration curve was linear(r =0.999 9) in thioctic acid concentration range of 0.4-20.0 mg/L.The limit of detection (LOD) for thioctic acid was 0.2 mg/L and the limit of quantitation(LOQ) was 0.6 mg/L.The relative standard deviation(RSD,n =12)was 3.4%,and the average spiked recovery was 100.9% with RSD of 2.0%.The proposed method could be applied in the determination of relative substances in thioctic acid tablets with the advantages of simplicity,rapidity,accuracy,good selectivity and high sensitivity.

关键词

硫辛酸片/硫辛酸/降解物/高效液相色谱法

Key words

thioctic acid tablet/thioctic acid/degradation products/HPLC

分类

化学化工

引用本文复制引用

叶汝汉,张怡,彭蕾,孙晋红,张嘉颖,张慧影,伍迪科,张萍..硫辛酸片含量与降解物的高效液相色谱测定研究[J].分析测试学报,2013,32(7):894-897,4.

基金项目

广东省科技计划项目(2010A040209001) (2010A040209001)

分析测试学报

OA北大核心CSCDCSTPCD

1004-4957

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