High-Throughput Analysis of Pharmaceutical Tablet Content Uniformity by Near-Infrared Chemical Imaging

摘要

The feasibility of measuring the content uniformity of multiple drug tablets simultaneously using a near-infrared chemical imaging (NIR-CI) system was evaluated. A total of 20 tablets including five calibration and 15 unknown samples were measured at once using a large field of view (59.5 mm X 47.5 mm). In this multitablet measurement, each calibration and unknown sample was described by approximately 3000 pixels on the infrared camera, in which each pixel measures 186 (mu)m X 186 (mu)m of the sample surface area. The content uniformity of unknown samples predicted by NIR-CI was compared with the results from the conventional UV method. To examine the impact of the sample location in this large field of view, measurements of the same samples located at different positions were also performed, and the results compared. As a result of the evaluation, the content of individual tablets obtained by NIR-CI shows excellent agreement with the reference UV method values. Moreover, it was further determined that changing the position of any given tablets in the array had a negligible effect when the calibration tablets were under the same field of view. This article demonstrates the use of NIR-CI for simultaneous measurement of content uniformity for multiple tablets and discusses some advantages of this approach.