Development and validation of NIR-chemometric methods for chemical and pharmaceutical characterization of meloxicam tablets. (April 2014)

• Record Type: Journal Article
• Authors: Tomuta, Ioan; Iovanov, Rares; Bodoki, Ede; Vonica, Loredana
• Is Part Of: Drug development and industrial pharmacy. Volume 40:Number 4(2014:Apr.)
• Page Start: 549
• Page End: 559
• Publication Date: 2014-04
• Subjects: Pharmaceutical chemistry -- Periodicals; Pharmaceutical industry -- Periodicals; Drug Industry -- Periodicals; Technology, Pharmaceutical -- Periodicals; 615.05
• DOI: 10.3109/03639045.2013.772193
• Languages: English
• ISSNs: 0363-9045

Abstract

<abstract> <title>Abstract</title> <p> <italic>Context</italic>: 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.</p> <p> <italic>Objective</italic>: 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.</p> <p> <italic>Materials and methods</italic>: 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.</p> <p> <italic>Results</italic>: 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.</p> <p> <italic>Discussion</italic>: 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).</p> <p> <italic>Conclusion</italic>: 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.</p> </abstract>