SIMULTANEOUS QUANTIFICATION OF ATORVASTATIN AND
AMLODIPINE IN POWDER BLENDS FOR TABLETING BY NIR
SPECTROSCOPY AND CHEMOMETRY
ANDREEA LOREDANA VONICA-GLIGOR1, 2, 3, TIBOR CASIAN1, ANDRA REZNEK1, IOAN TOMUȚĂ1*, FELICIA GLIGOR2
1"Iuliu Haţieganu" University of Medicine and Pharmacy Cluj-Napoca, 400023, Romania
2“Lucian Blaga” University, Lucian Blaga, 2A, Sibiu, 550169, Romania
3S.C. Polipharma INDUSTRIES, Sibiu, 550052, Romania
*corresponding author: tomutaioan@umfcluj.ro
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Abstract:
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.

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