A New method for simultaneous qualitative and quantitative determination of amlodipine besylate and atorvastatin calcium in bulk and pharmaceutical formulations using transmission FT-IR spectroscopy

Abstract

A simple, precise, rapid, and eco-friendly FTIR spectrophotometric method was developed and validated for simultaneous analysis of amlodipine (AML) and atorvastatin (ATV) in drug combination preparations. Firstly, synthetic mixtures were made and scanned with FTIR instrument. Then the result spectra were converted automatically to absorbance spectra. The calibration model was made depending on Beer's law which relates concentration to absorbance. Two characteristic bands corresponding to the carbonyl group at 1708-1688 cm−1 and 1660-1632 cm−1 for AML and ATV, respectively, were selected for quantification. The absorbance of a series of standards was measured as the AUC of the chosen bands. Then, the calibration line was obtained by plotting the measured AUCs and the actual concentrations against each other. Validation tests were performed per ICH recommendations. Specificity was evaluated by the separation of APIs and excipients from marketed preparations by methanol. Then, the spectra of extracted excipients, APIs, and pharmaceutical samples were taken and overlapped. The selected peaks were specific and did not interfere with each other or other peaks from the excipients used in the tablet's matrix. Linearity for AML and ATV was in the range of 0.1–1% w/w with excellent coefficients of determination (R2), 0.998 and 0.999 for AML and ATV, respectively. The proposed analytical method was accurate and precious, as the RSD values were less than 2%. The proposed FTIR method was successfully applied to estimate the exact quantity of APIs in pharmaceutical samples. Recoveries were accepted in accordance with USP and were in the range of 94.62–100.6% and 98.175–101.06% for AML and ATV, respectively. Likewise, the acquired results were compared with the HPLC method. And the t- and F- tests were calculated and compared with the theoretical values, which indicate the similarity of results in both developed and reported methods.