ATR–FTIR-Based Direct and Rapid Quantification of Levofloxacin, Degradation and Adulterations via Multivariate Analysis

Abstract

The rapid and direct drug quantification is indispensable for quality control units in the pharmaceutical sector to assure safe formulation and delivery of the right medicine to patients. Spectral features of Levofloxacin (LFX) were examined to provide a Fourier transform infrared spectroscopy (FTIR)-based rapid and pragmatic analytical method for direct quantification of LFX in solid formulations. A chemometric model was developed for frequency region of 1252.39–1218.84 cm−1 which is linear over the range of 30%–90% (w/w) with a coefficient of determination (R2) 0.995 and meets the requirements of International Council for Harmonization (ICH) and AOAC for the development of the method. The limit of detection (LOD) and limit of quantification (LOQ) were found to 7.616% w/w and 23.079% w/w, respectively. Principal component analysis (PCA) was performed to identify adulteration or degradation of active pharmaceutical ingredients (APIs). It was observed that PC1 and PC2 explained 99.93% and 99.91% of the IR spectral variance respectively. Consequently, this method can be applied for routine analysis of LFX and quality control in pharmaceutical regulatory laboratories.