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Drug Dev Ind Pharm. 2014 Apr;40(4):549-59. doi: 10.3109/03639045.2013.772193. Epub 2013 Apr 17.

Development and validation of NIR-chemometric methods for chemical and pharmaceutical characterization of meloxicam tablets.

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1
Department of Pharmaceutical Technology and Biopharmaceutics .

Abstract

CONTEXT:

Near-Infrared (NIR) spectroscopy is an important component of a Process Analytical Technology (PAT) toolbox and is a key technology for enabling the rapid analysis of pharmaceutical tablets.

OBJECTIVE:

The aim of this research work was to develop and validate NIR-chemometric methods not only for the determination of active pharmaceutical ingredients content but also pharmaceutical properties (crushing strength, disintegration time) of meloxicam tablets.

MATERIALS AND METHODS:

The development of the method for active content assay was performed on samples corresponding to 80%, 90%, 100%, 110% and 120% of meloxicam content and the development of the methods for pharmaceutical characterization was performed on samples prepared at seven different compression forces (ranging from 7 to 45 kN) using NIR transmission spectra of intact tablets and PLS as a regression method.

RESULTS:

The results show that the developed methods have good trueness, precision and accuracy and are appropriate for direct active content assay in tablets (ranging from 12 to 18 mg/tablet) and also for predicting crushing strength and disintegration time of intact meloxicam tablets.

DISCUSSION:

The comparative data show that the proposed methods are in good agreement with the reference methods currently used for the characterization of meloxicam tablets (HPLC-UV methods for the assay and European Pharmacopeia methods for determining the crushing strength and disintegration time).

CONCLUSION:

The results show the possibility to predict both chemical properties (active content) and physical/pharmaceutical properties (crushing strength and disintegration time) directly, without any sample preparation, from the same NIR transmission spectrum of meloxicam tablets.

PMID:
23594301
DOI:
10.3109/03639045.2013.772193
[Indexed for MEDLINE]

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