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Trends in Chromatography   Volumes    Volume 10 
Abstract
Development of HPTLC-densitometry methods for quantifying naproxen sodium, loperamide hydrochloride and loratadine in pharmaceutical tablets using a model procedure reported earlier to transfer TLC screening methods for fake and substandard drugs
Danhui Zhang, Jacob Strock, Joseph Sherma
Pages: 1 - 5
Number of pages: 5
Trends in Chromatography
Volume 10 

Copyright © 2016 Research Trends. All rights reserved

ABSTRACT
 
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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