Issue 16, 2013

NIR reflectance determination of warfarin in a solid preparation commercialized at different API mass proportions

Abstract

Due to the need of accurate control of their therapeutic doses, warfarin-containing medicines are marketed in preparations with low, but different warfarin contents. A single near infrared reflectance procedure is proposed for warfarin determination in four different doses of a commercial preparation, with PLS as multivariate calibration tool and with an active pharmaceutical ingredient proportion ranging from one to five per cent of mass tablet. A mixed calibration sample set, composed of commercial samples and laboratory compacted tablets was prepared. In order to achieve suitable accuracy and precision, the difference in scattering between laboratory and commercial tablets was reduced by studying the effect of the compaction pressure. Also a spectral pre-treatment was applied, consisting of a second derivative followed by the Standard Normal Variate (SNV) normalization of the derivative spectra. The wavelength range 1480–1560 nm had to be deleted since a shift of an absorption band of lactose was detected after tablet compaction under laboratory conditions. No significant differences were found between the NIR prediction and HPLC reference data of the validation sample set.

Graphical abstract: NIR reflectance determination of warfarin in a solid preparation commercialized at different API mass proportions

Article information

Article type
Paper
Submitted
22 Mar 2013
Accepted
10 May 2013
First published
13 May 2013

Anal. Methods, 2013,5, 3858-3863

NIR reflectance determination of warfarin in a solid preparation commercialized at different API mass proportions

J. Arruabarrena, J. Coello and S. Maspoch, Anal. Methods, 2013, 5, 3858 DOI: 10.1039/C3AY40488A

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