Determination of Three Impurity Ions in Oral Rehydration Salt Powder(Ⅲ)by Gradient Elution Ion Chromatography
10.3870/j.issn.1004-0781.2025.10.024
- VernacularTitle:梯度淋洗离子色谱法同时测定口服补液盐散(Ⅲ)中3种杂质离子
- Author:
Hao NIE
1
;
Jingxin XIE
;
Mengmeng SHEN
;
Li ZHU
;
Xu WANG
Author Information
1. 安徽医科大学生命科学学院,合肥 230032
- Publication Type:Journal Article
- Keywords:
Oral rehydration salt powder(Ⅲ);
Bromide ion;
Nitrite ion;
Oxalate ion;
Ion chromatography
- From:
Herald of Medicine
2025;44(10):1667-1670
- CountryChina
- Language:Chinese
-
Abstract:
Objective To establish an efficient,sensitive,and accurate ion chromatography method for the simultaneous determination of three impurity ions—bromide(Br-),nitrite(NO2-),and oxalate(C2 O42-)—in oral rehydration salts powder(Ⅲ).These impurity ions may pose potential toxic side effects on children's health;therefore,ensuring their content within safe limits is crucial for safeguarding pediatric medication safety.Methods A Metrosep A Supp 5 column(250 mm×4.0 mm,5 μm),packed with quaternary ammonium-bonded polyvinyl alcohol was used.The eluent consisted of carbonate buffer:Mobile phase A was a mixture of 3.2 mmol·L-1 sodium carbonate and 1.0 mmol·L-1 sodium bicarbonate(50∶50,V∶V),and mobile phase B was a mixture of 32 mmol·L-1 sodium carbonate and 10 mmol·L-1 sodium bicarbonate(50∶50,V∶V),with gradient elution.The column temperature was set at 35℃,and the flow rate was 0.7 mL·min-1.Limits for the three impurity ions were set according to the International Council for Harmonisation guidelines(ICH M7(R1)and ICH Q3B),and the method was validated by testing six actual samples.Results Within the concentration range of 0.02-0.50 μg·mL-1,the linear correlation coefficients(R2)for the three impurity ions were all greater than 0.999.The detection limits ranged from 1.2 to 3.4 ng·mL-1,and the spiked recovery rates were between 92.0%and 102.0%.Results from the six actual samples demonstrated that the method effectively controlled the content of impurity ions.Conclusion This study successfully established a gradient elution ion chromatography method for the simultaneous determination of three impurity ions in Oral rehydration salts powder(Ⅲ).The method is highly sensitive,specific,and accurate.
