Determination of ten bacteriostatic agents in Kangfuxin Solution by HPLC-DAD method
10.19778/j.chp.2024.03.011
- VernacularTitle:HPLC-DAD法测定康复新液中10种抑菌剂含量
- Author:
Wanqing ZHANG
1
;
Wenyan ZHENG
;
Caimei WANG
;
Li QIAO
;
Xiaoxiao LIU
Author Information
1. 广东省药品检验所,广州 510700
- Keywords:
kangfuxin solution;
HPLC-DAD;
bacteriostatic agent;
benzoic acid;
sorbic acid;
methyl 4-hydroxy-benzoate;
chlorhexidine acetate
- From:
Drug Standards of China
2024;25(3):282-288
- CountryChina
- Language:Chinese
-
Abstract:
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.
