University of Medicine and Pharmacy „Iuliu Haţieganu”, Faculty of Pharmacy Department of Pharmaceutical Technology and Biopharmaceutics, , Cluj-Napoca, ROMANIA Chemical characterization concerning API and excipients content of the extended release tablets with quetiapine using NIR-chemometric methods T. Dragan*, A. Muntean, I. Tomuta, A.L. Vonica * corresponding author: INTRODUCTION In recent years, the application of near infrared (NIR) spectroscopy as a monitoring technique within the pharmaceutical industry has grown rapidly. NIR spectroscopy has been used as a powerful tool for raw material testing, product quality control and process monitoring. The growing pharmaceutical interest in NIR is probably a direct result of its advantages of being simple, fast, and non-destructive, and enabling the analysis of complex matrices without the need to manipulate samples. NIR spectra are rich in chemical and physical information when it is used in conjunction with appropriate chemometric modeling techniques. The major step to develop a NIR assay method is calibration procedure for model development. Once a calibration is developed and favorable predictions are expected, they must be validated to be accepted for routine use. The aim of this study is to develop and validate a NIR-chemometric methods for quantification of API (quetiapine) and two excipients in extended release tablets without any sample preparation. MATERIALES AND METHODS Materials: quetiapine fumarat (PharmaZell, India), microcrystalline cellulose (JRS Pharma, Germany), lactose monohydrate (Meggle, Germany), HPMC 100M, HPMC 100LV - (Colorcon, UK), silicon dioxide – Aerosil200 (Rohm Pharma Polymers, Germany), magnesium stearat (Merck, Germany). Apparatus and software: the tablets were analysed using a NIR model Antaris II FT-NIR Analyser (TermoElectron, SUA) in Reflectance Sampling configuration. For recording NIR spectra it was used Opus QUANT programme (Bruker Optics, Germania). Preparation of samples for NIR calibration: the tablets were obtained by direct compression of the powder blend using a Korsch EK 0 machine. The powder formulation is presented in table I. For calibration it was used a matrix of experimental design (Table II) with 3 factors (quetiapine, HPMC, microcrystalline cellulose) and 5 levels of API concentration ( %). CONCLUSIONS Different calibration models were evaluated for quetiapine and excipients quantification in tablets in using NIR-chemometic technique. Using the best calibration models the methods were fully validated according with ICH guidance for direct quantification of quetiapine, HPMC and microcrystalline cellulose. In conclusion, the NIR-chemometric methods have suitable reproducibility, accuracy and linearity and can be used for chemical characterization of extended release tablets with quetiapine. RESULTS : Fig 1. Validation results of NIR method for quatiapine assay Fig 2. Validation results of NIR method for HPMC assay Fig 3. Validation results of NIR method for microcrystalline cellulose assay