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On-Line Content Uniformity Determination of Tablets Using Low-Resolution Raman Spectroscopy

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Abstract:

Analytical techniques for rapid and nondestructive content uniformity determination of pharmaceutical solid dosage forms have been studied for several years in an effort to replace the traditional wet chemistry procedures, which are labor intensive and time consuming. Both Raman spectroscopy and near-infrared spectroscopy have been used for this purpose, and predictability errors are approaching those of the traditional techniques. In this study, a low-resolution Raman spectrometer was utilized to demonstrate the feasibility of both rapid at-line and on-line determination of tablet content uniformity. Additionally, sampling statistics were reviewed in an effort to determine how many tablets should be assayed for specific batch sizes. A good correlation was observed between assay values determined by high-performance liquid chromatography and Raman analysis. Due to rapid acquisition times for the Raman data, it was possible to analyze far more samples than with wet chemistry methods, leading to a better statistical description of variation within the batch. For at-line experiments, the sampling volume was increased by rotating the laser beam during the acquisition period. For the on-line experiments, the sampling volume was increased by sampling from a stream of tablets moving underneath the Raman probe on a conveyor system. Finally, an approach is proposed for monitoring content uniformity immediately following the compaction process. In conclusion, Raman spectroscopy has potential as a rapid, nondestructive technique for at- or on-line determination of tablet content uniformity.

Keywords: CENTRAL LIMIT THEOREM; CONTENT UNIFORMITY; PROCESS ANALYTICAL TECHNOLOGY; RAMAN SPECTROSCOPY; SAMPLING

Document Type: Research Article

DOI: http://dx.doi.org/10.1366/000370206777670684

Affiliations: 1: Department of Industrial and Physical Pharmacy, School of Pharmacy, Purdue University, West Lafayette, Indiana 47907 2: Department of Physical Chemistry, School of Science, Purdue University, West Lafayette, Indiana 47907 3: School of Industrial Engineering, College of Engineering, Purdue University, West Lafayette, Indiana 47907 4: Department of Management and Management Information Systems, College of Business, University of West Florida, Pensacola, Florida 32514 5: Chemistry Department, Faculty of Science, University of British Columbia, Vancouver, British Columbia, Canada V6T 1Z1

Publication date: June 1, 2006

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