摘要
目的:建立梯度洗脱HPLC法,以双波长同时测定不同厂家曲安奈德益康唑乳膏中4种抑菌剂含量。方法:采用Waters Symmetry C 18(250 mm×4.6 mm,5μm)色谱柱,以甲醇为流动相A,以甲醇-0.02 mol·L^(-1)磷酸二氢钠溶液(95∶5)为流动相B,梯度洗脱,流速为1.0 mL·min-1,柱温为35℃,检测波长为228 nm、254 nm。结果:本法可有效分离曲安奈德益康唑乳膏中各色谱峰,苯甲酸、羟苯甲酯、羟苯乙酯和羟苯丙酯分别在0.010348~0.15522 mg·mL^(-1)、0.009876~0.148145 mg·mL^(-1)、0.010106~0.151588 mg·mL^(-1)、0.010259~0.153882 mg·mL^(-1)范围内与峰面积线性关系良好;平均回收率(n=9)分别为99.68%(RSD=2.35%)、100.21%(RSD=1.78%)、100.47%(RSD=1.59%)、100.06%(RSD=1.65%),检测限分别为3×10^(-5)mg·mL^(-1)、1.67×10^(-5)mg·mL^(-1)、1.67×10^(-5)mg·mL^(-1)、1.67×10^(-5)mg·mL^(-1)。结论:本研究建立的曲安奈德益康唑乳膏中抑菌剂的含量测定方法,方法灵敏、准确,色谱峰分离良好,为其质量控制提供了依据。
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 C 18 column(250 mm×4.6 mm,5μm)under gradient elution of methanol(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 0.010348-0.15522 mg·mL^(-1),0.009876-0.148145 mg·mL^(-1),0.010106-0.151588 mg·mL^(-1)and 0.010259-0.153882 mg·mL^(-1)respectively.The average 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 acetonide econazole cream.
作者
李震
刘明鹭
栾曾惠
于玮洁
杨钊
LI Zhen;LIU Minglu;LUAN Zenghui;YU Weijie;YANG Zhao(Qingdao Institute for Food and Drug Control,Qingdao 261000,China;Qingdao Women and Children′s Hospital,Qingdao 261000,China)
出处
《中国药品标准》
CAS
2024年第2期204-208,共5页
Drug Standards of China
关键词
曲安奈德益康唑乳膏
抑菌剂
苯甲酸
羟苯甲酯
羟苯乙酯
羟苯丙酯
triamcinolone acetonide econazole cream
bacteriostatic agent
benzoic acid
methyl hydroxybenzoate
ethylparaben
propylparaben
