关键词: 乙酰半胱氨酸, 苯甲酸钠, 羟苯甲酯, HPLC

Abstract:

Objective： To develop an HPLC method for simultaneous determination of acetylcysteine，sodium benzoate and methylparaben in acetylcysteine oral solution.Methods： The analytical experiment was performed on Ultimate LP-C18 column（4.6 mm × 250 mm，5 μm） with 0.1% phosphate acid solution as mobile phase A and 0.1% phosphate acetonitrile solution as mobile phase B.Gradient elution was performed at the flow rate of 1.0 mL·min^-1. The detection wavelength was 215 nm. The column temperature was 30 ℃， and the injection volume was 10 μL.Results： The quantitation limit concentration of acetylcysteine， sodium benzoate，methylparaben respectively was 0.003 57， 0.000 23， 0.000 12 mg·mL^-1. The detection limit concentration respectively was 0.001 19， 0.000 08， 0.000 04 mg·mL^-1. The linear ranges for acetylcysteine， sodium benzoate， methylparaben were 0.499-1.496， 0.038-0.113， 0.025-0.075 mg·mL^-1 （r≥0.999 9）. The average recovery was 99.6% （RSD=0.934%）， 100.3% （RSD=0.909%）， and 99.7% （RSD=1.837%） （n=12）， respectively.Conclusion： The established HPLC method is simply operable， efficient， accurate and reproducible， which could be used for the quantitative determination of acetylcysteine and bateriostatic agents in acetylcysteine oral solution.

Key words:  , Acetylcysteine； , Sodium benzoate； , Methylparaben； , HPLC