Akademik Veri Yönetim Sistemi
Ankara Universitesi Eczacilik Fakultesi Dergisi, cilt.49, sa.3, ss.827-837, 2025 (Scopus, TRDizin)
Objective: Fixed-dose formulations, such as combination of atorvastatin (AT) and ezetimibe (EZ), present analytical challenges due to overlapping spectral features in UV-Vis spectroscopy. Although traditional chromatographic methods are effective in these cases, they are not cost-efficient, and the required instrumentation is not easily accessible. This study aims to develop a simpler, cost-effective spectrophotometry-based approach for the simultaneous quantification of AT and EZ in fixed-dose formulations. Material and Method: Principal component regression (PCR) and partial least squares (PLS) regression models were used in combination with UV-Vis spectroscopy. A calibration set of binary mixtures was prepared in the working range of 4–36 µg/ml for both drugs. PCR and PLS models were constructed using three latent variables. The developed methods were evaluated for accuracy, precision, and selectivity using laboratory-prepared samples. The applicability of the methods was demonstrated by analyzing commercial tablet samples. Result and Discussion: Both models achieved high recovery rates (98–102.3%) and low relative standard deviations (<2.0%), confirming their accuracy and precision. Standard addition studies confirmed the selectivity of the methods. Then, the proposed PCR and PLS methods successfully quantified AT and EZ in commercial film-coated tablets without extensive sample preparation, offering a simple, cost-effective, and efficient alternative to conventional techniques.