COMPARATIVE PERFORMANCE OF LIQUID CHROMATOGRAPHY AND SPECTROPHOTOMETRY FOR QUANTITATIVE ANALYSIS OF PARACETAMOL IN TABLETS FORMULATIONS

Several techniques have been developed and validated for analyzing paracetamol in pharmaceutical formulations, including Ultra High-Performance Liquid Chromatography (UHPLC). This study employed a validated method for analyzing three commercially available paracetamol products. The chromatographic separation utilized a mobile phase consisting of a 70:30 v/v ratio of methanol to water. The separation process was carried out using a C18 Rapid Resolution column (4.6 x 100 mm, 3.5 µm, Agilent HPLC Column). The maximum wavelength (λmax) for paracetamol estimation was determined at 243 nm. The separation process was achieved using an injection volume of 20 μl and a run time of 3.0 minutes. The method exhibited linearity within the concentration range of 10-150 μg/ml for Paracetamol. The validation of the method followed the International Conference on Harmonization (ICH) guidelines, covering assessments of specificity, selectivity, linearity, accuracy, and precision, as well as the lower limit of quantification (LLOQ), and lower limit of detection (LLOD). The LLOQ and LLOD for paracetamol were established at 250 ng/ml and 100 ng/ml, respectively. The assay percentage for all pharmaceutical products containing paracetamol met the acceptable criteria range of 90-110%. These methodologies have proven effective for the accurate quantitative analysis of paracetamol in pharmaceutical formulations.