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Updated: May 14, 2026

Application and Methodology of the Non-destructive 19F Time-domain NMR Technique to Measure the Content in Fluorine-containing Drug Products
Published on: August 22, 2017
High-throughput NIR-chemometric methods for determination of drug content and pharmaceutical properties of indapamide
Ioan Tomuta1, Lucia Rus, Rares Iovanov
1University of Medicine and Pharmacy Iuliu Hatieganu Cluj-Napoca, Department of Pharmaceutical Technology and Biopharmaceutics, 41 Victor Babes Street, 400023, Cluj-Napoca, Romania. tomutaioan@umfcluj.ro
Abstract:
This paper describes the development, validation and application of NIR-chemometric methods for API content and pharmaceutical characterization (disintegration time and crushing strength) of indapamide intact tablets. Development of the method for chemical characterization was performed on samples corresponding to 80, 90, 100, 110 and 120% of indapamide content and for pharmaceutical characterization on samples prepared at nine different compression forces (covering the interval 7-45 kN). NIR spectra of prepared tablets were recorded in transmission mode, and partial least-squares followed by leave-one-out cross-validation were used to develop models for the prediction of the drug content and the pharmaceutical properties of tablets. All developed models were validated in terms of trueness, precision and accuracy. No statistical differences were found between results predicted by NIR-chemometric methods and the ones determined by reference methods. Therefore, the developed NIR-chemometric methods meet the requirements of a high-throughput method for the determination of drug content, pharmaceutical properties of indapamide tablets.
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