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, 5m), 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. ambroxol hydrochloride and levocetirizine dihydrochloride were exposed to acidic, alkali, oxidative, thermal and photolytic stress conditions and the stressed samples were analysed by the proposed method. Peak homogeneity data of ambroxol hydrochloride and levocetirizine dihydrochloride in the stressed samples demonstrated the specificity of the method for their estimation in presence of degradants. The described method was linear over a range of 15 45 g/mL for ambroxol hydrochloride and 1 3 g/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.
Highlights
IntroductionIts mucolytic activity by which it facilitates breakdown of acid mucopolysaccharide fibres in the mucous making it thinner and less viscous and, easy for expectoration
Ambroxol hydrochloride (ABH) [1] chemically known as trans-4-[(2-Amino-3,5-dibromo benzyl) amino] cyclo hexanol hydrochloride is an activeN-desmethyl metabolite of the mucolytic, bromhexine
3.1 Method development: Several mobile phase compositions were tried to resolve the peaks of ambroxol hydrochloride, levocetirizine dihydrochloride and degraded components
Summary
Its mucolytic activity by which it facilitates breakdown of acid mucopolysaccharide fibres in the mucous making it thinner and less viscous and, easy for expectoration. It stimulates production of pulmonary surfactant, a substance found to play a major role in the lung host defence mechanism, thereby further protecting against lung inflammation and infection. (phenyl) methyl] piperazin-1-yl)ethoxy) acetic acid dihydrochloride, the (R) enantiomer of cetirizine, is a potent and selective antagonist of peripheral H1-receptors. It has high affinity for human H1- receptors
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