High-throughput NIR-chemometric methods for determination of drug content and pharmaceutical properties of indapamide tablets

Simultaneous Quantification of Paracetamol and Caffeine in Powder Blends for Tableting by NIR-Chemometry

“…There are several validation parameters that must be determined in order to be consistent with the recommendations of the International Conference of Harmonization (ICH) and with other guidelines: accuracy, precision (repeatability and intermediate precision), linearity, and range of application. The validation was performed according to the strategy proposed by Hubert et al, [18,19] and adapted by the authors for NIR methods [10,22,23].…”

“…The number of factors for the experimental data obtained in calibration has to be chosen so that to avoid "over fitting." There were different methods proposed in order to select the optimum number of factors [22,23]. Root mean square error of prediction (RMSEP) was used as a diagnostic test to assess the predictive ability of the model.…”

Multivariate Calibration for the Development of Vibrational Spectroscopic Methods

“…Different settings of a one-process factor were enough to induce variability in physical properties of the samples [15]. In a similar study, Tomuta et al developed NIR method for physicochemical characterization of low active content indapamide tablets (2%, w/w) [1]. Virtanen et al evaluated the crushing strength of theophylline tablets through Raman spectroscopy by considering both a process factor and a formulation factor to generate variability in tablet surface roughness.…”

“…In such cases, each type of interferences has to be considered in the calibration model development. In the following section, the importance of chemical, physical, and environmental interferences will be described, providing insights on specific spectral variations produced by each category and highlighting how to handle them in order to increase model robustness [1,2].…”

“…Considering the pharmaceutical domain, these methods have been extensively applied to quantify active pharmaceutical ingredients, excipients, or physical properties either as offline method for intermediate/final product characterization [1] or as real-time-monitoring methods implemented within blending [2], granulation [3], extrusion [4], tableting [5], coating [6], or freeze-drying processes [7].…”