Simultaneous Determination of Nine Bacteriostatic Agents in Shengmai Drink by HPLC
Objective To establish a high-performance liquid chromatography(HPLC)method for simultaneously determining the contents of nine bacteriostatic agents in Shengmai Drink,and to investigate the addition of bacteriostatic agents in the formulation.Methods The chromatographic column was the Shiseido Capcell Pak MG Ⅱ C18 column(250 mm×4.6 mm,5 µm),the mobile phase was 0.02 mol/L ammonium acetate solution-methanol(gradient elution),the flow rate was 1.0 mL/min,and the detection wavelengths were 230 nm(benzoic acid)and 254 nm(potassium sorbate,methylparaben,ethylparaben,propylparaben,butylparaben,isobutyl 4-hydroxybenzoate,pentyl 4-hydroxybenzoate,phenyl 4-hydroxybenzoate),the column temperature was 30℃,and the injection volume was 20 µL.Thirty-eight batches of samples from 16 manufacturing enterprises(all of which were evaluative samples in Jiangsu in 2022)were selected and diluted at different proportions,and the contents of nine bacteriostatic agents were determined.Results The linear ranges of the nine components to be tested were 0.011-1.062 µg,0.010-1.001 µg,0.010-0.971 µg,0.011-1.047 µg,0.010-0.956 µg,0.010-1.039 µg,0.010-0.958 µg,0.011-1.108 µg,0.010-1.032 µg(r≥0.998 3),respectively.The RSDs of precision,stability and repeatability tests were all lower than 2.0%.The average recovery rates of the above nine components were in the range of 91.47%-97.16%,with RSDs in the range of 0.15%-1.24%(n=6).Among the 38 batches of samples from 16 manufacturing enterprises,there were few cases of adding bacteriostatic agents not included in the prescription or over the standard limit.Conclusion This method is accurate and specific,which can be used for the determination of bacteriostatic agents in Shengmai Drink.
Shengmai Drinkbacteriostatic agentHPLCquality control
万方数据
维普
