DEVELOPMENT AND VALIDATION OF ANALYTICAL METHODOLOGY BY HPLC FOR THE SIMULTANEOUS QUANTIFICATION OF PHENYLEPHRINE HYDROCHLORIDE, PARACETAMOL AND CHLORPHENIRAMINE MALEATE TABLETS

Abstract

It is developed and validated an analytical method for the simultaneous quantification of phenylephrine hydrochloride, Paracetamol, salicylamide, chlorpheniramine maleate and Caffeine tablets using Liquid Chromatography High Resolution reversed phase (HPLC-RP). The mobile phase consisted of phosphate buffer pH 3.5 and wavelength of 202 nm ultraviolet detector for phenylephrine hydrochloride, 298 nm for Paracetamol, Chlorpheniramine maleate to 205 nm, 262 nm for Salicylamide and Caffeine. a good chromatographic separation using a column filled L11 phenyl silica was achieved. The retention time for each analyte was 8.6 Phenylephrine hydrochloride for, for Paracetamol 17.7, 22.2 for salicylamide, caffeine and 23.7 to 31.2 Chlorpheniramine maleate for using gradient elution with acetonitrile in proportion of 20% maximum along the chromatographic run. The precision and accuracy was greater than 98% for the 5 assets and the running time was 40 minutes per sample. Specificity, linearity, accuracy and precision of the chromatographic method implemented can be implemented routinely.