High-throughput NIR-chemometric methods for determination of drug content and pharmaceutical properties of indapamide powder blends for tabletting.

This paper describes the development and application of NIR-chemometric methods for active content assay and pharmaceutical characterization (granulometric analysis and flowability assessment) of indapamide powder blends for tabletting. Indapamide powder blends were prepared and their NIR spectra were recorded in reflectance mode. Partial least-squares (PLS) regression followed by leave-one-out cross-validation was used to develop calibration models for predicting the indapamide content and pharmaceutical properties. The method for indapamide assay was validated in terms of trueness, precision, accuracy. The near infrared based property predictions were compared with the reference method results and no significant differences were found between the reference and predicted characteristics. The developed NIR-chemometric methods can be useful tools for prediction of active content, granulometric properties and parameters related to flowability of pharmaceutical powders.