Rapid screening of pharmaceuticals by thin-layer chromatography: analysis of essential drugs by visual methods.
A method for rapidly screening pharmaceuticals by thin-layer chromatography has been designed for use in areas with limited resources and by operators with limited training. An apparatus for performing the analysis in a plastic bag under equilibrium conditions was designed. Results can be reproduced by different operators and in different locations. The analysis can be performed without electricity or in a remote area, away from a laboratory. It is especially suited for field use in developing countries. The method is low cost, maintenance-free, fast, and reliable; it also uses limited volumes of solvents. The analyses can be performed without weighing if reference materials can be supplied in tablet form, provided the drug content is listed and only one unit is required for each analysis. All procedures were developed for the analysis of drugs from a partial list of essential drugs established by the World Health Organization. Three drugs were selected and prepared in the form of reference tablets. Comparisons with the analyses of the drugs in standard dosage forms were made by using reference tablets and primary USP standards. Comparable results were obtained, proving that the screening process can be conducted by using reference tablets and without weighing either the sample or the reference. The method has been successfully demonstrated and used in Swaziland, by high school teachers in the United States, and by personnel from the Ministry of Health in Saudi Arabia. Personnel can be trained in a short time to perform screening analysis of drugs.
Kenyon
A S
AS
U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Division of Drug Analysis, St. Louis, MO 63101-2045.
Flinn
P E
PE
Layloff
T P
TP
D002214:Capsules / Q000032:analysis; D002855:Chromatography, Thin Layer; D003720:Densitometry; D004364:Pharmaceutical Preparations / Q000032:analysis*; D012015:Reference Standards; D013607:Tablets / Q000032:analysis
D002214:Capsules; D004364:Pharmaceutical Preparations; D013607:Tablets