Content determination of sodium pyrosulfite and sodium sulphate in phentolamine mesylate injection by ion chromatography
10.12173/j.issn.1008-049X.202402015
- VernacularTitle:离子色谱法测定甲磺酸酚妥拉明注射液中焦亚硫酸钠及硫酸钠的含量
- Author:
Wan WANG
1
;
Shi LUO
;
Hongyu CHEN
;
Xiaofei WANG
;
Feicheng PENG
;
Yuxin LI
Author Information
1. 湖南省药品检验检测研究院(长沙 410001)
- Keywords:
Ion chromatography;
Phentolamine mesylate injection;
Sodium metabisulfite;
Sodium sulfate;
Content determination
- From:
China Pharmacist
2024;27(4):545-550
- CountryChina
- Language:Chinese
-
Abstract:
Objective To establish a method for the determination of contents of sodium metabisulfite and sodium sulfate in phentolamine mesylate injection.Methods The ion chromatography method with a DionexIonPac AS11-HC(250 mm×4.0 mm,5 pm)column was used,with potassium hydroxide solution as eluent,gradient elution,flow rate of 1.0 mL/min.The column temperature was 30 ℃ and the injection volume was 25 μL.Results Sodium metabisulfite showed good linearity(r=0.999 3)in the range of 10.596-211.920 μg/mL,and its average recovery rate was 100.00％,with an RSD of 1.4％(n=9).Sodium sulfate showed good linearity(r=0.999 8)in the range of 1.027-20.540 μg/mL,and its average recovery rate was 99.96％,with an RSD of 1.8％(n=9).Conclusion The established method is simple,accurate,sensitive and suitable for the determination of sodium metabisulfite and sodium sulfate contents in phentolamine methylate injection.
