Analysis of Artemisinin-Based Combination Therapy (ACT) in Bulk and Formulations by Fourier Transform Infrared Spectrophotometry

Abstract

A simple, rapid, and precise FTIR spectroscopic method was developed and validated for the simultaneous estimation of Artemether (ART) and Lumefantrine (LUM) in both bulk and pharmaceutical formulations. The method is based on measuring specific absorption bands: the ether functional group at 1113.10–1091.77 cm⁻¹ for ART and the phenyl substitution band at 893.65–857.08 cm⁻¹ for LUM. These characteristic peaks were not interfered with by any of the formulation excipients. Method validation was performed in accordance with ICH guidelines. Calibration curves demonstrated linearity in the concentration range of 17–470 mg for ART and 10–250 mg for LUM, with correlation coefficients (r²) of 0.999 for both drugs. Precision, assessed by repeatability, showed % RSD values of 0.831% for both intraday and interday analyses. Accuracy was confirmed through recovery studies using the standard addition method at three concentration levels (80%, 100%, and 120%), yielding mean recoveries of 99.8 ± 0.556% for ART and 99.9 ± 0.094% for LUM. The % assay values obtained from the calibration curve were 99.0 ± 0.1% for ART and 99.9 ± 0.1% for LUM, indicating close agreement with labeled claims. The validated method is suitable for routine analysis of ART and LUM in bulk drug and tablet dosage forms.