Determination of ten bacteriostatic agents in Kangfuxin Solution by HPLC-DAD method
Objective:To establish a high-performance liquid chromatography(HPLC)method for the simultaneous determination of 10 bacteriostatic agents in Kangfuxin solution.Methods:The HPLC method parameters were as follows,a Thermo AcclaimTM 120 column(4.6 mm × 250 mm,5 μm),a gradient mobile phase of 0.1%glacial acetic acid-0.02 mol·L-1 ammonium acetate solution and methanol at a flow rate of 1 mL·min-1,and the scan-ning wavelength of 200-700 nm.Results:In the corresponding concentration range,the linear relationship be-tween the mass concentration of the 10 bacteriostatic agents and the peak area was good(r≥0.999 8);the preci-sion was good with RSD of 0.33%-0.38%;The RSD values of the repeatability test and the stability test were<0.5%,the recovery rate was 97.4%-101.1%,and the RSD was between 0.4%-1.8%.According to the pro-posed method,the content results of benzoic acid,sorbic acid,hydroxyphenyl ethyl ester and hydroxyphenyl propyl ester in the test sample were 0.15-0.34%,0-0.48%,0-0.02%,and 0-0.02%,respectively.Conclu-sion:This method is sensitive,rapid,specific and accurate,and can be used for the determination of the content of bacteriostatic agents in Kangfuxin solution.