Development and Validation of A Reverse-Phase High Performance Liquid Chromatography Analysis for Paracetamol in Tablets Formulations


A simple yet sensitive high performance liquid chromatography method was developed and validated for the determination of paracetamol (PCM) content in different tablets dosage form. The mobile phase consisted of a mixture of methanol: water (80:20 v/v). The HPLC analysis was performed at a flow rate of 1 mL/min using a Thermo Synchronise C18 (150 × 4.6mm, 5μM) and an UV detection wavelength of 254 nm was used. The method was validated for selectivity, linearity, precision, accuracy, limit of quantification (LOQ), limit of detection (LOD), robustness and solution stability. The calibration curve was linear over a concentration range of 20 to 70 µg/mL (r2 = 0.9997) with LOD and LOQ of 0.01 and 0.03 μg/mL, respectively. The retention time for paracetamol was 1.5 min. The relative standard deviation percent (%RSD) and the relative error percent (%RE) of calibration curve were between 0.03-1.03% and 0.05-1.11%, respectively. The intra- and inter-day precision and accuracy were between 0.02-1.55% and 0.10-0.78%, respectively. In addition, the %RSD of short term stability and the method robustness were between 0.4-1.20% and 0.09-1.43%, respectively. All results followed the ICH guideline Q2 (R1) which indicates the precision and accuracy of the developed method. The method was successfully applied to assess PCM content in different marketed tablets in Iraq.