DEVELOPMENT OF STABILITY INDICATING RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF AMBROXOL HYDROCHLORIDE AND LEVOCETIRIZINE DIHYDROCHLORIDE

Abstract

A simple, precise and accurate method has been developed for simultaneous estimation of Ambroxol hydrochloride and Levocetirizine dihydrochloride. The proposed RP-HPLC method utilises Enable C18 G column (250 x 4.6mm, 5µm), mobile phase consisting of Phosphate buffer pH 3.0: Methanol in the ratio of 20:80 (v/v) and UV detection at 236nm using a photodiode array detector.The stability indicating capability of the method was proven by subjecting the drugs to stress conditions such as alkaline and acid hydrolysis, oxidation, photolysis, thermal degradation as per ich guidelines and resolution of the degradation products formed therein.The described method was linear over a range of 15-45 µg/mL for ambroxol hydrochloride and 1-3 µg/mL for levocetirizine dihydrochloride respectively. The method validation data showed excellent results for accuracy, precision, linearity, specificity, limit of detection, limit of quantification and robustness. The present method can be successfully used for routine quality control and stability studies.