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,2μm),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5~25μg·mL^(-1)内线性关系良好(r=0.9999),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。
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,2μm)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 5−25μg·mL^(-1)(r=0.9999),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.
作者
朱彦丹
陈斌
应津津
汤小丽
蔡华路
ZHU Yandan;CHEN Bin;YING Jinjin;TANG Xiaoli;CAI Hualu(Zhejiang Jinhua Conba Bio-pharm Co.,Ltd.,Jinhua 321016,China)
出处
《中国现代应用药学》
CAS
CSCD
北大核心
2021年第22期2864-2867,共4页
Chinese Journal of Modern Applied Pharmacy