A Screen-Printed Potentiometric Sensor for Stability Indicating Assay and Real-Time Monitoring of Trospium Chloride Dissolution Profile in its Pharmaceutical Dosage Form

Abstract

According to FDA guidance, a biowaiver concept declares that dissolution testing could be approved as a replacement strategy for bioequivalence studies and/or in vivo bioavailability. From the analytical chemistry standpoint, the shift from the classically developed offline methods to the highly integrated miniaturized inline analyzers is one of the pioneering ways that would modernize future of in-vitro - in-vivo correlation (IVIVC). The emergence of screen-printed electrodes (SPE) is now making the move from successive sampling steps and off-line measurements to real-time and in-line monitoring. Recently, “SPE” potentiometric sensor was presented as real-time analyzer that can offer similar analytical results as separation-based chromatographic techniques. Thus, the main objective of this paper is to design a real-time SPE for in situ monitoring of the dissolution of trospium chloride (TRO) in neutral media. Validation of the proposed sensor was performed according to the IUPAC commendations. The measurements performed with this sensor showed an accuracy of average recovery 100.50% and standard deviation of less than 1.0%, also the repeatability and intermediate electrode variabilities were less than 1.0 and 1.3%, respectively. The developed sensor was successfully used for direct observation of the dissolution profile without any need for an extraction step or sample preparation.