Simultaneous determination of Amlodipine and Atovastatin in a multicomponent drug using infrared spectroscopy coupled with multivatiate analysis

Abstract

The development and validation of a UV spectroscopy method combined with multivariate analysis methods including classical least squares, principal component regression, and partial least squares were performed to simultaneously quantify Amlodipine (AML) and Atorvastatin (ATO). A central composite design experimental method was used to construct calibration and validation sets. UV absorption spectra were measured in the wavelength range of 230-260 nm. Multivariate regression methods were constructed based on the measured spectra of the calibration and validation sets, resulting in: R² > 0.9927, RMSEC_AML < 1 ppm, RMSEC_ATO < 2 ppm, and relative prediction error (REP) < 5%. The recovery ranged from 99.20% - 108.13% for AML and 99.10% - 107.19% for ATO for all three methods. The repeatability (RSD) was smaller than the Horwitz value. ANOVA analysis compared the mean values of the methods with the HPLC method, and no significant differences were found. The simultaneous quantification of AML and ATO in Zoamco-a tablets resulted in AML and ATO content within the range of 90-110% of the labeled content, which complies with the regulations of the Vietnamese Pharmacopoeia V.