Simultaneous determination of 4 bacteriostatic agents in triamcinolon acetonide econazole cream by HPLC under gradient elution
10.19778/j.chp.2024.02.016
- VernacularTitle:HPLC法梯度洗脱同时测定曲安奈德益康唑乳膏中4种抑菌剂的含量
- Author:
Zhen LI
1
;
Minglu LIU
;
Zenghui LUAN
;
Weijie YU
;
Zhao YANG
Author Information
1. 青岛市食品药品检验研究院,山东青岛 261000
- Keywords:
triamcinolone acetonide econazole cream;
bacteriostatic agent;
benzoic acid;
methyl hydroxybenzoate;
ethylparaben;
propylparaben
- From:
Drug Standards of China
2024;25(2):204-208
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To develop an HPLC method with gradient elution for the simultaneous determination of 4 bacteriostatic agents in triamcinolone acetonide econazole cream from the different manufacturers.Methods:The test was performed on a Waters Symmetry C18 column(250 mm ×4.6 mm,5 μm)under gradient elution of metha-nol(A)and methanol-0.02 mol·L-1 sodium dihydrogen phosphate solution(B).The flow rate of 1.0 mL·min-1 and the column temperature was 35 ℃.The detection wavelengths were 228 nm and 254 nm.Results:The good separation of the bacteriostatic agents peaks were achieved.The linear ranges of benzoic acid,methyl hydroxybenzoate,ethylparaben and propylparaben fell into 0.010 348-0.155 22 mg·mL-1,0.009 876-0.148145 mg·mL-1,0.010 106-0.151 588 mg·mL-1 and 0.010 259-0.153 882 mg·mL-1 respectively.The av-erage recoveries were 99.68%(RSD=2.35%),100.21%(RSD=1.78%),100.47%(RSD=1.59%)and 100.06%(RSD=1.65%)respectively.The LODs were 3 × 10-5 mg·mL-1,1.67 × 10-5 mg·mL-1,1.67 × 10-5 mg·mL-1 and 1.67 × 10-5 mg·mL-1 respectively.Conclusion:The established method is sensitive and accurate,and has the good separation.It provides the reliable basis for the quality control of triamcinolone ace-tonide econazole cream.