QUANTIFICATION OF MELOXICAM AND
EXCIPIENTS ON INTACT TABLETS BY NEAR
INFRARED SPECTROMETRY AND
CHEMOMETRY.
I. TOMUŢĂ*, R. IOVANOV, E. BODOKI, S.E. LEUCUŢA
Department of Pharmaceutical Technology and Biopharmaceutics,
Faculty of Pharmacy, ”Iuliu Hatieganu” University, Cluj-Napoca,
400023, Romania
*corresponding author: tomutaioan@umfcluj.ro
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Abstract:

The purpose of the present work was to develop a Near Infra Red (NIR) – chemometic method for the quantitation of a pharmaceutical active ingredient and excipients in tablets which is readily applicable to tablet testing. Tablets containingn meloxicam as an active pharmaceutical ingredient (API) and tableting excipients at various nconcentrations were prepared by direct compression. An experimental design approach was used in generating a 5-level (%, w/w) calibration sample set that included 28 samples. Their NIR spectra were measured by transmittance technique. High-performance liquid chromatography (HPLC) was used as a reference method for the meloxicam assay. Calibration models were generated by partial least-squares (PLS) and principal component regression (PCR) method followed by leave-one-out cross-validations. These calibration models with or without spectral pretreatment were used to predict the drug and excipients content in the tablets made for model validation. The result showed that Standard Normal Variate (SNV) spectral pretreatment with PLS calibration method is suitable for the quantitative analysis of meloxicam API and two excipients (isomalt and microcrystalline cellulose) in tablet formulation..

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