Simultaneous high-performance liquid chromatography determination of paracetamol and ascorbic acid in tablet dosage forms

Abstract

A simple, specific, precise and accurate reversed phase liquid chromatographic (RP-LC) method has been developed for the simultaneous determination of paracetamol and ascorbic acid in tablet dosage form. The chromatographic separation was achieved on a LiChrosorb C18, 250 mm × 4.6 mm, 5 μm column at a detector wavelength of 254 nm and a flow rate of 1.0 ml min-1. The mobile phase was 1 mM sodium pentane sulphonate in a mixture of 0.4 volume of formic acid, 25 volume of methanol and 75 volume of water. The retention times for ascorbic acid and paracetamol were found to be 3.53 and 6.09 min, respectively. The method was validated for parameters like specificity, linearity, precision, accuracy, robustness, limit of quantitation and limit of detection. The method was found to be specific as no other peaks of impurities and excipients were observed. The square of correlation coefficients (R2) for paracetamol and ascorbic acid were 0.9999 and 0.9998 while percentage mean recoveries were 99.16 and 98.76%, respectively. Intra- and inter-day relative standard deviations for both the components were <2.0%. The proposed RP-LC method can be applied for the routine analysis of commercially available formulations of these drugs either as such or in combination. Key words: Liquid chromatography, validation, paracetamol, ascorbic acid.