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SIMULTANEOUS QUANTIFICATION OF ATORVASTATIN AND AMLODIPINE IN POWDER BLENDS FOR TABLETING BY NIR SPECTROSCOPY AND CHEMOMETRY

ANDREEA LOREDANA VONICA-GLIGOR^1,2,3, TIBOR CASIAN¹, ANDRA REZNEK¹, IOAN TOMUȚĂ^1*, FELICIA GLIGOR²

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A Near Infrared (NIR)-chemometric method for the direct and simultaneous quantification of atorvastatin and amlodipine in pharmaceutical powder blends for tableting was developed and fully validated. A calibration model was developed based on the 26 samples prepared according to a D-optimal experimental design with 2 factors and 5 levels. For the quantification of atorvastatin the best predictive model was developed using first derivative followed by standard normal variate preprocessing method, 3 partial least squares (PLS) factors and 4 spectral regions; for the quantification of amlodipine the best predictive model was developed using the same pre-processing method, 6 PLS factors and 4 spectral regions. The validation results showed that the method is reproducible, precise and has satisfactory accuracy and linearity profiles for the simultaneous assay of atorvastatin and amlodipine in powder blends for tableting without any sample preparation. The comparative data obtained on independent samples showed no statistical difference (p > 0.05) between the results predicted by the NIR method and the values obtained by the HPLC reference method. This fast NIR-chemometric method requires no sample preparation and may be implemented for in-line, on-line or at-line blend uniformity evaluation of the mixing step of atorvastatin and amlodipine tablets manufacturing process.