[en] FT-NIR transmission ; PAT ; tablet assay ; validation ; UV-vis assay ; solid dosage form ; PLS model
[en] For several years, near-infrared spectroscopy (NIRS) has become an analytical technique of great interest for the pharmaceutical industry, particularly for the non-destructive analysis of dosage forms. The goal of this study is to show the capacity of this new technique to assay the active ingredient in low-dosage tablets. NIR spectroscopy is a rapid, non-destructive technique and does not need any sample preparation. As an example, a binary mixture of microcrystalline cellulose and riboflavin was used to prepare tablets of different weights by direct compression. A prediction model was built by using a partial least square regression fit method. The NIR assay was performed by transmission. The results obtained by NIR spectroscopy were compared with a conventional UV-vis spectrophotometry method. The study showed that tablets can be individually analysed by NIR with high accuracy. It was shown that the variability of this new technique is less important than that of the conventional method which is the UV-vis spectrophotometry. (c) 2006 Elsevier B.V. All rights reserved.