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Simultaneous determination of some multicomponent dosage forms by quantitative thin layer chromatography
1National Organization for Drug Control and Research, Cairo, Egypt.
Journal of Pharmaceutical and Biomedical Analysis
|March 7, 2000
Summary
A thin layer chromatography densitometric method was developed for simultaneous analysis of drug mixtures. This method accurately quantifies naproxen, diflunisal, paracetamol, chlorzoxazone, and other compounds in pharmaceutical formulations.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Analysis
- Chromatography
Background:
- Accurate quantification of active pharmaceutical ingredients in complex mixtures is crucial for quality control.
- Existing analytical methods may lack the efficiency or specificity for simultaneous determination of multiple drugs.
Purpose of the Study:
- To develop and validate a thin layer chromatography densitometric method for the simultaneous determination of three distinct multicomponent drug mixtures.
- To assess the method's applicability in analyzing pharmaceutical formulations.
Main Methods:
- Thin layer chromatography (TLC) coupled with densitometry was employed.
- Optimized mobile phases (ethyl acetate: methanol: ammonia 25% and ethyl acetate) were used for separating specific drug combinations.
- Retention factor (Rf) values were determined for each analyte.
Main Results:
- The method successfully separated and quantified components in mixtures containing naproxen/diflunisal, paracetamol/chlorzoxazone, and chlorphenoxamine hydrochloride/8-chlorotheophylline/caffeine.
- Linearity, recovery, and precision were evaluated, demonstrating the method's reliability.
- The TLC-densitometric method was successfully applied to pharmaceutical formulations like tablets, capsules, and suppositories.
Conclusions:
- The developed thin layer chromatography densitometric method provides an efficient and accurate approach for the simultaneous analysis of multicomponent pharmaceutical mixtures.
- The method's successful application to various dosage forms validates its utility in pharmaceutical quality control.
- Statistical comparison confirmed the method's efficacy against reported alternative techniques.