Near Infrared (NIR) Analysis of Tablets Containing Two Active Ingredients

Robert Mattes1, Denise Root1, Ed Brunson2, Suresh Potharaju 2, James Johnson2, Almoazen Hassan 2, 1FOSS NIRSystems, Inc., 2University of Tennessee, Department of Pharmaceutical Sciences

Abstract

Near infrared (NIR) analysis of tablets provides a fast, accurate means of monitoring tablets during production that meets with PAT initiatives. Dosage forms with multiple active pharmaceutical ingredients (APIs) pose greater analytical difficulties than single API dosage forms. This study evaluates NIR analysis of tablets containing 4 mg Chlorpheniramine maleate (CPM) and 10 mg phenylephrine HCL per dosage. The tablets were produced with nominal batch levels to include a range of +/- 20% of each ingredient by the University of Tennessee Pharmaceutical Sciences Department. Ten tablets from each batch level, for a total of ninety tablets, were tested and HPLC was run on each batch. Partial least squares regression models were developed for both APIs and predictive capability of the models was analyzed.