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引用本文:朱彦丹,陈斌,应津津,汤小丽,蔡华路.HPLC测定乙酰半胱氨酸溶液中EDTA-2Na含量[J].中国现代应用药学,2021,38(22):2864-2867.
ZHU Yandan,CHEN Bin,YING Jinjin,TANG Xiaoli,CAI Hualu.Determination of EDTA-2Na in Acetylcysteine Solution by HPLC[J].Chin J Mod Appl Pharm(中国现代应用药学),2021,38(22):2864-2867.
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HPLC测定乙酰半胱氨酸溶液中EDTA-2Na含量
朱彦丹, 陈斌, 应津津, 汤小丽, 蔡华路
浙江金华康恩贝生物制药有限公司, 浙江 金华 321016
摘要:
目的 建立乙酰半胱氨酸溶液中EDTA-2Na含量测定的HPLC。方法 色谱柱为ACE Excel 2 AQ (150 mm×2.1 mm,2 μm),柱温40℃,流动相A为0.4%磷酸溶液,流动相B为0.4%磷酸甲醇溶液,梯度洗脱,流速0.2 mL·min–1,检测波长为205 nm。结果 EDTA-2Na在5~25 μg·mL–1内线性关系良好(r=0.999 9),3个浓度的平均回收率均>99%,RSD均≤0.5%,EDTA-2Na与溶液中其他组分能有效分离(分离度>2)。结论 本法不需要衍生处理,简便、快速、准确,可用于乙酰半胱氨酸溶液中EDTA-2Na的含量测定。
关键词:  乙酰半胱氨酸溶液  含量测定  EDTA-2Na  高效液相色谱法
DOI:10.13748/j.cnki.issn1007-7693.2021.22.018
分类号:R917.101
基金项目:
Determination of EDTA-2Na in Acetylcysteine Solution by HPLC
ZHU Yandan, CHEN Bin, YING Jinjin, TANG Xiaoli, CAI Hualu
Zhejiang Jinhua Conba Bio-pharm Co., Ltd., Jinhua 321016, China
Abstract:
OBJECTIVE To establish an HPLC method for determination of the content of EDTA-2Na in acetylcysteine solution. METHODS ACE Excel 2 AQ column(150 mm×2.1 mm, 2 μm) was used with the column temperature of 40℃. The mobile phase A was 0.4% phosphoric acid, the mobile phase B was 0.4% phosphoric acid methanol solution, and the gradient elution was used. The flow rate was 0.2 mL·min-1. The detector wavelength was 205 nm. RESULTS EDTA-2Na had a good linearity in the range of 5-25 μg·mL-1(r=0.999 9), the average recovery of the 3 concentrations was >99%, and the RSD was ≤ 0.5%, EDTA-2Na and the other components in the solution could be separated effectively(the resolution was >2). CONCLUSION The method does not require derivation, it is simple, rapid and accurate, which can be used for the determination of the content of EDTA-2Na in acetylcysteine solution.
Key words:  acetylcysteine solution  content determination  EDTA-2Na  HPLC
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