摘要
目的:建立采用现代检测手段同时测定氢达乳膏制剂中三个主要成分盐酸达克罗宁、羟苯乙酯、氢化可的松含量的检定方法。方法:采用Agilent C18(250 mm×4.6 mm,5μm)色谱柱,以枸橼酸-磷酸氢二钠缓冲液(含0.2%枸橼酸和0.2%磷酸氢二钠)-甲醇(34∶66)为流动相,流速为0.6 mL/min,柱温为25℃,测定波长为256 nm。结果:盐酸达克罗宁、羟苯乙酯、氢化可的松的线性范围分别为0.155~0.464μg(r=0.9998)、0.015~0.045μg(r=0.9998)、0.151~0.452μg(r=0.9998);检出限(3 S/N)分别为0.396 ng、0.058 ng、0.235 ng;平均加样回收率分别为98.00%、99.15%、99.30%,RSD分别为1.08%、0.70%、1.03%。结论:该方法简便而准确,并可用于控制制剂氢达乳膏的产品质量。
Objective:To establish a modern method for the simultaneous determination of dyclonine hydrochloride,ethylparaben and hydrocortisone in qingda cream.Methods:The chromatographic separation was performed on a Agilent C18 column(250 mm×4.6 mm,5μm)with a mixture of citric acid disodium hydrogen phosphate buffer solution(containing 0.2%citric acid and 0.2%disodium hydrogen phosphate)-methanol(34∶66)as mobile phase at the flow rate of 0.6 mL/min,the column temperature was maintained at 25℃and the detection wavelength was 256 nm.Results:The revised curves in the whole range of 0.155-0.464μg(r=0.9998)for dyclonine hydrochloride and 0.015-0.045μg(r=0.9998)for ethylparaben and 0.151-0.452μg(r=0.9998)for hydrocortisone were good linear,and the detection limits(3 S/N)were 0.396 ng,0.058 ng and 0.235 ng respectively.The average rates of recovery were 98.00%,99.15%and 99.30%;RSD were 1.08%and 0.70%and 1.03%.Conclusion:An accurate method can be used for the quality control of qingda cream.
作者
丁志军
李小兰
付志媛
DING Zhijun;LI Xiaolan;FU Zhiyuan(Dermatology Hospital of Jiangxi Province,Nanchang Jiangxi 330001,China;Jiangxi Province Clinical Research Center For Skin Diseases,Nanchang Jiangxi 330001,China;Candidate Branch of National Clinical Research Center for Skin Diseases,Nanchang Jiangxi 330001,China)
出处
《药品评价》
CAS
2022年第11期655-658,共4页
Drug Evaluation
基金
江西省药品监督管理局科研项目(2020JS17)。
