Abstract
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. 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 the conventional HPLC method for Montelukast tablets produced by Sigma pharmaceutical corp. The study showed that Montelukast tablets can be individually analyzed by NIR with high accuracy. It was shown that the variability of this new tech- nique is less important than that of the conventional method which is the HPLC with UV detection.
Highlights
The Food and Drug Administration adopt what is known as process analytical technology (PAT) initiative which is a collaboration effort with industry to facilitate the introduction of new and efficient manufacturing technologies
The results obtained by NIR spectroscopy were compared with the conventional HPLC method for Montelukast tablets produced by Sigma pharmaceutical corp
All materials are of pharmaceutical grade and include microcrystalline cellulose, magnesium stearate, Croscarmellose sodium and Aerosil 200 are kindly supplied by Sigma pharmaceuticals Corp., to be of the same type used for preparation of Montelukast tablets
Summary
The Food and Drug Administration adopt what is known as process analytical technology (PAT) initiative which is a collaboration effort with industry to facilitate the introduction of new and efficient manufacturing technologies. PAT are systems for design, analysis, and control of manufacturing processes, based on timely measurements of critical quality and performance attributes of raw and in-process materials and products, to assure high quality of products at the completion of manufacturing (http://www.fda.gov/cder) [1]. PAT includes scientifically based process design that identifies key measurements of product quality and the critical process variables that affect them, appropriate measurement devices, statistical information technology tools, and feedback process control strategies that work together to ensure production of final products with the desired quality. Several vibrational spectroscopy techniques are used for the application of PAT in the on-line monitoring of the pharmaceutical process. Near-infrared spectroscopy (NIRS) has become an analytical technique of great interest for the pharmaceutical Industry. The NIR region spans the wavelength range 12,500 4000 cm–1
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