An earlier reported model process for transfer of Global Pharma Health Fund E.V. Minilab® Manual and U.S. Food and Drug Administration (FDA) Compendium thin layer chromatography (TLC) screening methods for fake and substandard pharmaceuticals to quantitative high performance TLC-densitometry methods was used to develop and validate analyses of tablets containing naproxen sodium, loperamide hydrochloride and loratadine. Only readily available, inexpensive, and relatively nontoxic ‘green’ solvents specified in the model process were used for sample preparation and the mobile phases. The new methods were used to assay three tablets of each drug in triplicate within the calibration range of 70-130% of the label value, and results were validated for accuracy, precision, peak purity and peak identity according to the criteria of the model. TLC screening methods for these products are not available in either the Minilab® Manual or FDA Compendium, and we were able to develop, test and publish new methods for naproxen sodium and loratadine online in a Supplement to the Compendium.
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