Sustainable environment-friendly quantitative determination of three anti-hyperlipidemic statin drugs and ezetimibe in binary mixtures by first derivative Fourier transform infrared (FTIR) spectroscopy.

Abstract

FTIR spectrometry is considered a sustainable green analytical chemistry procedure. Its use in quantitative analysis of pharmaceutical compounds in their raw resources and in their dosage forms is growing currently. The current research offers an environment-friendly, speedy, cost-effective, reliable and easy method for the simultaneous estimation of anti-hyperlipidemic drugs. No sample preparation was required except for grinding and mixing with KBr for making pellets used for acquisition of the FT-IR spectra. First-derivative FTIR spectroscopy is used to assess quantitatively atorvastatin (ATR), rosuvastatin (RSV) and simvastatin (SMV) in their binary mixtures with ezetimibe (EZT). For the first mixture, EZT and ATR were determined at 1733.18cm-1 and 1647.74cm-1, respectively. In the second mixture, the zero-crossing wave numbers selected for the determination of EZT and RSV were 1733.18cm-1 and 955.69cm-1, correspondingly. Whereas, the third mixture was quantified at the wavenumbers of 1520.93 and 3569.68cm-1 for EZT and SMV, respectively. Validation of the procedure has been performed complying with recommendations of the International Conference of Harmonization (ICH) presenting linearity, accuracy, precision, robustness and selectivity. The linear range for all drugs was 2-30mg/g. It was found that the LOD was 0.607, 0.311, 0.491 and 0.395mg/g and the LOQ was found to be 1.839, 0.942, 1.490 and 1.190mg/g for EZT, ATR, RSV, and SMV, correspondingly. The proposed technique was found to be accurate and precise in terms of percentage error and percentage relative standard deviation among intraday and interday measurements. It was also found selective through comparison of the results of standard drugs with results of binary mixtures and of pharmaceutical tablets. It was found robust through making slight variations in the working conditions and the results obtained remained statistically equivalent. The technique was applied effectively for the estimation of the binary mixtures under study in their tablets. Comparing the found outcomes to those of reference derivative UV spectrophotometric methods gave no significant difference between them. Analytical eco-scale and the scale of Green Analytical Procedure Index (GAPI) are the two scales utilized for evaluation of the greenness of the technique and it was found to be excellent green.