Volume 9 ; Issue 1 ; in Month : Jan-June (2025) Article No : 187
Pekcan G, Koçak K, Aktaş AH.

Abstract

A novel spectrophotometric-chemometric approach has been developed for the concurrent quantitative determination of cholesterol-lowering drugs ezetimibe and simvastatin in pharmaceutical formulations. The proposed method integrates spectrophotometry with chemometric techniques, thereby enhancing analytical precision and accuracy. The spectral data were obtained in the ultraviolet-visible (UV-Vis) range and processed using multivariate calibration methods, including principal component regression (PCR) and partial least squares (PLS) regression.. This approach offers a cost-effective and efficient alternative for routine quality control and analysis of combination cholesterol therapies. In the case of simvastatin and ezetimibe, the solutions prepared for the analysis of their spectroscopic properties were prepared in a concentration range of 1-40 µg/mL. The evaluation of the mean values and RMSD values has served as the foundation for determining the suitability of the analytical approach (0.0063; 0.008; 0.0018; 0.015). The calculated PRESS value is nearly negligible, thereby enhancing the degree of precision. The obtained PRESS values are sufficiently diminished (0.0082; 0.020; 0.0044; 0.010). The chemometric models effectively resolved the overlapping absorption spectra of ezetimibe and simvastatin, enabling their concurrent quantification without prior separation. The method was validated in accordance with ICH guidelines, demonstrating satisfactory linearity, sensitivity, and robustness. Application to commercial pharmaceutical samples yielded results consistent with labeled claims, confirming the method's reliability and practical applicability.

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