| 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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| 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: |
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| Determination of EDTA-2Na in Acetylcysteine Solution by HPLC |
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ZHU Yandan, CHEN Bin, YING Jinjin, TANG Xiaoli, CAI Hualu
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Zhejiang Jinhua Conba Bio-pharm Co., Ltd., Jinhua 321016, China
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| 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 |
