Development and validation of Micellar Liquid Chromatography method for analysis of Paracetamol and Ibuprofen in tablets dosage form

Abstract

The study describes the method development and validation of a green and isocratic micellar liquid chromatography (MLC) approach for the simultaneous estimation of Paracetamol and Ibuprofen in tablet formulations. This green chromatographic technique employs surfactant solutions as the activated mobile phase, once the Critical Micelle Concentration (CMC) is reached. The optimized MLC conditions showing high resolution and minimal peak tailing are the mobile phase containing 0.10 M SDS, 10 % 1-Propanol, 5 % Acetonitrile, 2 % Triethyl amine (pH-6.0) with a flow rate of 1.1 mL/min at 35 °C. It was clearly observed that the method used the universal separation of Paracetamol and Ibuprofen and the retention times are 1.644, 10.130 min and they were detected at 230 nm. Method validation using ICH methodologies proved that method was linear (r² > 0.998), precise (RSD <2 %), accurate (98.0–102.0 % recovery), specific, robust, and stable after 12 h in solution. Limits of detection and quantification were established at 3.0 μg and 10.0 μg for Paracetamol and 1.0 μg and 7.0 μg for Ibuprofen. This is a procedure applicable in regular quality control analysis and has the benefit of low toxicity, low environmental pollution and being useful even in complicated sample matrices. The findings confirm MLC as an effective, economical and enviable method of multispectral analysis of drugs, particularly analgesic/antipyretic medications such as Paracetamol and Ibuprofen whose use has been widespread.