SIMULTANEOUS ESTIMATION OF PHENYLEPHRINE HYDROCHLORIDE, PARACETAMOL, CAFFEINE AND CETIRIZINE DIHYDROCHLORIDE FROM TABLET DOSAGE FORM USING RP-HPLC
A reversed phase high performance liquid chromatography (RP-HPLC) method was developed and used for the simultaneous quantitative determination of Phenylephrine Hydrochloride (PHE), Paracetamol (PCM), Caffeine (CFN) and Cetirizine Dihydrochloride (CTZ) from its tablet dosage form. Chromatographic separation was performed on a Kromasil C18 column (250 mm x 4.6 mm, 5 ïm) with a mobile phase comprising of a mixture of mobile phase A (Potassium Dihydrogen Orthophosphate Buffer) and mobile phase B [Acetonitrile and Methanol (50:50)] (v/v), with gradient elution condition and pH adjusted to 3 with Orthophosphoric acid, at flow rate of 1.0 ml/min with PDA detector at 215 nm. Working standard of Phenylephrine Hydrochloride 50 µg/ml, Paracetamol 100 µg/ml, Caffeine 150 µg/ml and Cetirizine Hydrochloride 30 µg/ml were used to develop the assay method. Sample solution A containing 50 µg/ml of PHE, 150 µg/ml of CFN and 25 µg/ml of CTZ and another sample solution B containing 100 µg/ml of PCM were prepared from the tablet dosage form those were estimated by the developed method. From the result the assay % for all four drugs in sample preparation were found to be 99.95-100.30%, 100.58-100.45%, 84.01-87.63% and 102.00-102.33% for Phenylephrine, Caffeine, Cetirizine and Paracetamol respectively. The assay experiment shows that the method is free from interference of excipients. This demonstrates that the developed HPLC method is simple, linear, precise and accurate and can be conveniently adopted for the routine quality control analysis of the tablet