A simple, specific, accurate and precise RP-HPLC method has been developed and validated for the Simultaneous Estimation of Paracetamol and Tapentadol hydrochloride in their combined dosage form (tablet). The separation of the two components were carried out using C18 (250 mm × 4.6 mm id, 5 µm particle size) column by isocratic elution with a flow rate of 1 ml/min. The mobile phase composition was water: methanol: triethylamine (60:40:0.1) of pH 3.5 adjusted with orthophosphoric acid and detection was carried out at 225 nm. The retention time for Paracetamol was 3.92 min and 5.30 min for Tapentadol hydrochloride. The method has been validated in terms of linearity, specificity, accuracy, precision, limit of detection, limit of quantitation, robustness as per ICH guidelines. The method has been found to be linear in the range of 32.5-97.5 µg/ml (R2=0.9982) for Paracetamol and 5-15 µg/ml (R2=0.9977) for Tapentadol hydrochloride. The limit of detection and limit of quantitation were 0.0304 and 0.0922 for Paracetamol and 0.0086 and 0.0262 for Tapentadol hydrochloride. The recoveries of Paracetamol and Tapentadol hydrochloride were 99.97% and 99.81% respectively and their relative standard deviations were less than 2%. Hence, the method could be successfully applied for routine analysis of Paracetamol and Tapentadol hydrochloride in combined tablet dosage form.
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