薄层色谱法和化学法测定Momenta®乳膏的应用——三元混合物的对比研究

H. Salem, Omar Ma, Derayea Sm, Khalil Aa
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引用次数: 0

摘要

一项用于同时测定Momenta®乳膏中配制的糠酸莫米松(MF)、硝酸咪康唑(MIC)和庆大霉素(GM)的两种分析方法的验证和改进的比较研究。第一种方法是TLC光谱密度测定法,该方法是通过使用氯仿:甲醇:甲酸(4:0.3:0.15,v/v/v)作为流动相,在涂有硅胶60F254的TLC铝板上分离三种成分,然后使用Camage TLC扫描仪3在254nm下扫描,该扫描仪在反射-吸收模式下操作。第二种方法是使用两个模型的化学计量方法:偏最小二乘(PLS)和主成分回归模型(PCR)。根据ICH指南验证了所提出的方法,并将其应用于分析混合物和药物制剂中三元混合物的测定。
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Application of TLC-Spectrodensitometric and Chemometric Methods for Determination of Momenta® Cream: A Comparative Study Applied on Ternary Mixture
A comparative study for the validation and advancement of two analytical approaches applied for the simultaneous determination of Mometasone Furoate (MF), Miconazole Nitrate (MIC) and Gentamicin (GM) formulated in Momenta® cream. The first approach was TLC-spectrodensitometric method, which was advanced by separating the three components on TLC aluminum plates coated with silica gel 60 F254 using chloroform: methanol: formic acid (4:0.3:0.15, v/v/v) as a mobile phase, then scanned at 254nm using Camage TLC scanner 3 operated in reflectance-absorbance mode. The second approach was the chemometric method using two models: Partial Least Squares (PLS) and Principle Component Regression Model (PCR). The proposed approaches were validated according to ICH guidelines and were applied for the determination of the ternary mixtures in their analytical mixtures and pharmaceutical preparation.
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