Abstract

DEVELOPMENT AND VALIDATION OF UV-SPECTROSCOPIC METHOD FOR SIMULTANEOUS ESTIMATION OF AMBROXOL HCL AND LEVOCETRIZINE DI HCL IN BULK AND IN PHARMACEUTICAL DOSAGE FORM

Pathan Shabnam* and Nazma M. Inamdar

ABSTRACT

On the basis of the experiments, it was concluded that the UV method developed for the determination of ambroxol hydrochloride and levo-cetrizine dihydrochloride was validated and found to be sensitive, accurate, precise and reliable for routine analysis. Simple sensitive and reproducible method was developed for simultaneous estimation of ambroxol hydrochloride and levo-cetrizine dihydrochloride in bulk and in pharmaceutical formulation. Developed method was successfully applied to the pharmaceutical formulation. After development of the method it was validated as per ICH guidelines, in terms of specificity, linearity, precision, accuracy. In the present investigation of UV analysis, the method simultaneous estimation by Simultaneous equation Method is employed for the assay of AMB and LCTZ Pharmaceutical formulation. The solvent selected for stock solution preparation was methanol : water (50:50) and required concentrations were prepared by using the same. The λmax for detection of AMB and LCTZ were selected as 232nm and 246nm respectively.

Keywords: Ambroxol Hydrochloride, Levo-Cetrizine Dihydrochloride, UV, ICH.