Content determination of sodium pyrosulfite and sodium sulphate in phentolamine mesylate injection by ion chromatography
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.
Ion chromatographyPhentolamine mesylate injectionSodium metabisulfiteSodium sulfateContent determination