Validated Lc Method for Simultaneous Analysis of Paracetamol and Caffeine in Model Tablet Formulation

This paper describes development and validation of a high-performance liquid chromatographic analytical procedure for simultaneously determination of paracetamol and caffeine in a tablet formulation. The separation was achieved on a C18 column at a flow rate of 1.5 ml/min with UV detection at 220 nm. The mobile phase was composed of 1mM phosphate buffer pH 3.0 – acetonitrile (85:15 v/v) containing 0.2 % triethylamine (v/v). The method was validated for analytical parameters specificity, linearity, precision, accuracy, LOD, LOQ and robustness. The linearity of the method was investigated in the concentration ranges 31.25-250 μg/ml (r = 0.9999) for paracetamol and 4.06-32.50 μg/ml (r = 0.9986) for caffeine. Mean recoveries for paracetamol and caffeine were 99.37 and 99.12 %, respectively. The analytical procedure was applied to identification, purity and assay tests on model drug formulation. It was established that the developed analytical procedure was successfully used for routine analysis of paracetamol and caffeine in model drug dosage form without any interference from included excipients.