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Prediction of drug dissolution profiles from tablets using NIR diffuse reflectance spectroscopy: a rapid and nondestructive method.

Authors
Type
Published Article
Journal
Journal of Pharmaceutical and Biomedical Analysis
0731-7085
Publisher
Elsevier
Publication Date
Volume
39
Issue
1-2
Pages
17–21
Identifiers
PMID: 15935597
Source
Medline
License
Unknown

Abstract

A comparison between dissolution profiles obtained by using a dissolution apparatus (conventional method) and the NIR diffuse reflectance spectra of a series of clonazepam-containing batches is reported. Ten different formulations with fixed amount of clonazepam and varying proportions of excipients were analyzed at seven dissolution times and three different media. The percentages of dissolution of each sample were correlated with the NIR spectra of three tablets of each batch, through a multivariate analysis using the PLS regression algorithm. The squared correlation coefficients for the plots of percentages of dissolution from the equipment laboratory (dissolution apparatus and HPLC determination) versus the predicted values, in the leave-one-out cross-validation, varied from 0.80 to 0.92, indicating that the NIR diffuse reflectance spectroscopy method is an alternative, nondestructive tool for measurement of drug dissolution from tablets.

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