成分分析

高效液相色谱法测定化学对照品中8个有机酸的含量

  • 马玲云 ,
  • 孟雨馨 ,
  • 翟晨斐 ,
  • 冯玉飞 ,
  • 刘倩 ,
  • 牛剑钊 ,
  • 孙会敏
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  • 中国食品药品检定研究院,北京 100050
第一作者 马玲云 Tel:13681009480;E-mail:mlyun@nifdc.org.cn.
孟雨馨 Tel:15093796167;E-mail:myx15093796167@163.com
* 牛剑钊 Tel:(010)67095456;E-mail:njz@nifdc.org.cn
刘倩 Tel:13581828784;E-mail:liuqian@nifdc.org.cn

网络出版日期: 2025-10-13

Determination of eight organic acids in chemical reference standards by high performance liquid chromatography

  • MA Ling-yun ,
  • MENG Yu-xin ,
  • ZHAI Chen-fei ,
  • FENG Yu-fei ,
  • LIU Qian ,
  • NIU Jian-zhao ,
  • SUN Hui-min
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  • National Institutes for Food and Drug Control, Beijing 100050, China

Online published: 2025-10-13

摘要

目的: 建立适用于测定含L-酒石酸、苯磺酸、马来酸、琥珀酸、富马酸、枸橼酸、草酸、L-苹果酸化学对照品中有机酸含量的高效液相色谱法。方法: 采用Kromasil Eternity XT-5-C8(250 mm×4.6 mm,5 μm)色谱柱或Waters Xbridge C18(250 mm×4.6 mm,5 μm)色谱柱,以0.02 moL · L-1磷酸二氢钾溶液(A)-甲醇(B)为流动相,梯度洗脱,流速0.5 mL · min-1,检测波长210 nm,柱温20 ℃。结果: 8个有机酸在各自范围内线性关系良好(r≥0.999 8);精密度(RSD≤2%)、稳定性(RSD≤2%)、重复性(RSD≤2%)良好;平均加样回收率(n=9)为98%~102%。通过该方法对多种含有机酸化学对照品进行有机酸含量测定,理论值与测定值接近。结论: 该方法适用性良好,可用于含L-酒石酸、苯磺酸、马来酸、琥珀酸、富马酸、枸橼酸、草酸、L-苹果酸化学对照品中有机酸的含量测定。

本文引用格式

马玲云 , 孟雨馨 , 翟晨斐 , 冯玉飞 , 刘倩 , 牛剑钊 , 孙会敏 . 高效液相色谱法测定化学对照品中8个有机酸的含量[J]. 药物分析杂志, 2025 , 45(4) : 590 -597 . DOI: 10.16155/j.0254-1793.2024-0476

Abstract

Objective: To establish a high-performance liquid chromatography for the determination of L-tartaric acid, benzenesulfonic acid, maleic acid, succinic acid, fumaric acid, citric acid, oxalic acid and L-malic acid in chemical reference standards. Methods: The Kromasil Eternity XT-5-C8 (250 mm×4.6 mm,5 μm)column or Waters Xbridge C18 (250 mm×4.6 mm,5 μm)column was used. The mobile phase consisted of 0.02 moL · L-1 KH2PO4(A)-methanol (B), with gradient elution at 0.5 mL · min-1. Detection wavelength was 210 nm, the column temperature was 20 ℃. Results: All eight organic acids showed good linearity within their respective ranges (r≥0.999 8). The method demonstrated good precision (RSD≤2%), stability (RSD≤2%) and repeatability (RSD≤2%). The average recovery rate (n=9) was 98%-102%. The method was applied to the determination of organic acid content in various chemical reference standards containing organic acids, and the measured values closely matched the theoretical values. Conclusion: The method is suitable for the determination of L-tartaric acid, benzenesulfonic acid, maleic acid, succinic acid, fumaric acid, citric acid, oxalic acid and L-malic acid in chemical reference products.

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