SIMULTANEOUS & STABILITY INDICATING METHOD FOR DETERMINATION OF CETRIZINE HYDROCHLORIDE AND AMBROXOL HYDROCHLORIDE IN SYRUP

A simple isocratic HPLC method has been developed and validated as per ICH Guidelines for simultaneous and stability indicating determination of Cetirizine Hydrochloride and Ambroxol hydrochloride in pharmaceutical liquid oral dosage form syrup. Separation was achieved in Hypersil BDS C18 column, 5 μ, and 250 mm x 4.60 mm id with flow rate of 1.5 ml/minute and the detection at 230nm. 0.2 molar Ammonium phosphate with the pH of 4.0 with dilute orthophosphoric acid of about 65 percentage in acetonitrile combination was used as a mobile phase. Developed method validated as per ICH Guidelines, prior all the parameter system suitability was carried with five repeated injection of standard solution at the concentration of 50 μg/mL and 30 μg/mL Cetirizine Hydrochloride and Ambroxol Hydrochloride respectively. Percent RSD of five replicate injections of Cetirizine Hydrochloride and Ambroxol Hydrochloride and Tailing factor was found below 2.0% and 2.0 overall analyses respectively. A linear response was observed over the concentration range of 25.06 to 75.18 and 15.13 to 45.38ppm for the assay of Cetirizine Hydrochloride and Ambroxol Hydrochloride respectively. The results of analysis were validated statically and by recovery studies. Hence, the proposed method was found to be accurate, precise, reproducible and specific and can be used for simultaneous analysis of these drugs in liquid formulation