QUANTITATIVE CHARACTERIZATION OF
POWDER BLENDS FOR TABLETS WITH
INDAPAMIDE BY NEAR-INFRARED
SPECTROSCOPY AND CHEMOMETRY
CRISTINA SÎRBU1, IOAN TOMUTA1*, MARCELA ACHIM1, LIVIU
LUCA RUS2, LOREDANA VONICA2, ELENA DINTE1
1Department of Pharmaceutical Technology and Biopharmaceutics,
Faculty of Pharmacy, ”Iuliu Hatieganu” University, Cluj-Napoca, 400023,
Romania;
2S.C Polipharma Industries, Sibiu, 550052, Romania
*corresponding author: tomutaioan@umfcluj.ro
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Abstract:

A NIR-chemometric method, that is able to directly quantify the active
pharmaceutical ingredient (API) and two major excipients in pharmaceutical powder blends for manufacturing indapamide sustained release (SR) tablets, was developed and fully validated.
In order to develop calibration models for the assay of indapamide,
hydroxypropylmehylcelulose (HPMC) and lactose, the NIR spectra of 25 series of powder blends (prepared according to an experimental design) were recorded. Further, they were analyzed by testing different pre-processing methods and using partial least-square regression (PLS). Using the best calibration models: Second Derivate (SD) for indapamide,
First Derivate+Multiplicative Scatter Correction (FD+MSC) for HPMC and lactose, the methods were fully validated according to the ICH guidance.






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