Content determination of sodium pyrosulfite and sodium sulphate in phentolamine mesylate injection by ion chromatography

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Author: WANG Wan ¹ LUO Shi ² CHEN Hongyu ¹ WANG Xiaofei ¹ PENG Feicheng ¹  LI Yuxin ¹

Affiliation: 1. Hunan Institute for Drug Contrl, Changsha 410001, China 2. Hunan Drug Inspection Center, Changsha 410001, China

Keywords: Ion chromatography Phentolamine mesylate injection Sodium metabisulfite Sodium sulfate Content determination

DOI: 10.12173/j.issn.1008-049X.202402015

Reference: WANG Wan, LUO Shi, CHEN Hongyu, WANG Xiaofei, PENG Feicheng, LI Yuxin.Content determination of sodium pyrosulfite and sodium sulphate in phentolamine mesylate injection by ion chromatography[J].Zhongguo Yaoshi Zazhi,2024, 24(4):545-550.DOI: 10.12173/j.issn.1008-049X.202402015.[Article in Chinese]  Copied

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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 µm) 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.

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