Simultaneous Estimation of Levocetrizine Dihydrochloride and Ambroxol Hydrochloride in Syrup Dosage Form by Using Uv Spectrophotometric Method

Abstract

A simple, rapid, accurate, precise and economical UV Spectrophotometric method developed for simultaneous estimation of Levocetrizine dihydrochloride (LCTZ) and Ambroxol hydrochloride (AMB) in bulk and Syrup formulation and validate as per ICH guidelines. Determination of Levocetrizine dihydrochloride and Ambroxol hydrochloride in bulk and syrup was conducted by using simultaneous equation method based on measurement of absorbance at two wavelengths. The solvent used for proposed method was methanol: water (1:1). The λmax of Levocetrizine dihydrochloride and Ambroxol hydrochloride were found to be 231 nm and 246 nm, respectively. The linearity for LCTZ and AMB was in the range of 5-35 µg/ml and 5-50 µg/ml, respectively. The % recovery was found to be in the range of 99.52-99.82% and 100.37-100.72% for LCTZ and AMB, respectively. Percentage RSD for precision and accuracy of the method was found to be less than 2%. LOD values for LCTZ and AMB were found to be 3.0891 µg/ml and 3.1645 µg/ml, respectively. LOQ values for LCTZ and AMB were found to be 10.224 µg/ml and 10.474 µg/ml, respectively. Proposed method can be successfully employed for routine analysis of Levocetrizine dihydrochloride and Ambroxol hydrochloride in bulk and Syrup formulation.