Ft-Ir Spectroscopic Approach for the Quantitative Analysis of few Commercial Drugs in Bulk and Pharmaceutical Formulations

Abstract

A simple, rapid, environmentally benign, and cost-effective Fourier Transform Infrared (FT-IR) spectroscopic method was developed and validated for the quantitative determination of Nateglinide (NTG), Tolcapone (TCP), and Topiramate (TPR) in bulk drug substances and pharmaceutical formulations. The proposed analytical approach is based on the relationship between drug concentration and the intensity of characteristic infrared absorption bands, where variations in concentration produce corresponding changes in absorbance, enabling quantitative estimation through calibration models. The method was optimized by selecting suitable absorption bands with high sensitivity and reproducibility for each drug. Quantitative analysis of the selected pharmaceuticals in commercial tablet formulations was successfully performed without interference from formulation excipients, demonstrating the method's selectivity. Validation studies were carried out following accepted analytical guidelines, and the method was evaluated for linearity, accuracy, precision, limit of detection (LOD), limit of quantification (LOQ), robustness, and ruggedness. The developed procedure exhibited satisfactory analytical performance, with excellent linear correlations, low relative standard deviations, and acceptable recovery. The calibration curves established for the selected drugs were found to be reliable for routine quantitative analysis of both pure drug samples and pharmaceutical dosage forms. The absence of extensive sample preparation, reduced solvent consumption, and shorter analysis time make the proposed FT-IR method a practical and sustainable alternative to conventional analytical techniques. Therefore, the method can be effectively employed for quality control and routine assay applications in pharmaceutical industries and analytical laboratories.