HPLC was Used to Simultaneously Determine the Bacteriostatic Agent and Its Degradation Products in Ebastine Oral Solution
Objective:A high-performance liquid chromatography method was established for the simultaneous determination of the content of two bacteriostatic agents,sodium methylparaben and sodium propylparaben and their degradation products,p-hydroxybenzoic acid,in ebastine oral solution.Methods:The chromatographic column was Diamonsil C18 column(250 mm*4.6 mm,5 μm),the mobile phase was methanol-1％glacial acetic acid solution(58∶42),the flow rate was 1.0 mL/min,the column temperature was 40 ℃,the detection wavelength was 254 nm,and the injection volume was 20 μL.Results:The separation of the peaks of p-hydroxybenzoic acid,methylparaben and propylparaben was good,there was no interference in the negative samples,and the linear relationship between p-hydroxybenzoic acid in the range of 0.3391 mg/mL～3.3912 mg/mL was good(r=0.9997),the linear relationship between sodium methylparaben was good in the range of 4.8565 mg/mL～48.5654 mg/mL(r=0.9997),and the linear relationship between propylparaben was good in the range of 1.2004 mg/mL～1 2.0043 mg/mL(r=0.9995).The average recoveries of p-hydroxybenzoic acid,sodium methylparaben and sodium propylparaben were 99.71％(RSD:0.95％,n=12),99.82％(RSD:0.35％,n=9)and 100.65％(RSD:0.75％,n=9),respectively,and the test results of precision,repeatability and stability were good.Conclusion:This method is easy to operate,the results are accurate and the stability is good,and it can be used to determine the content of p-hydroxybenzoic acid in the two bacteriostatic agents and their degradation products in ebastine oral solution.
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