Abstract

VALIDATION AND DISSOLUTION METHOD DEVELOPMENT OF AMBROXOL HYDROCHLORIDE AND LEVOCETRIZINE HYDROCHLORIDE TABLETS

Sunita Patidar*, Deepika Bairagee, Divya Kanungo, Revathi A. Gupta, Nutan M. Gothwal

ABSTRACT

A simple, precise, accurate and economical dissolution method has been developed and validated for the simultaneous estimation of Ambroxol Hydrochloride and Levocetrizine Hydrochloride. The present work has been performed on Shimadzu UV-1700 series spectrometer and the drug release has been carried out on ELECTROLAB TDT–08L which is a microcontroller based 8-station dissolution apparatus. The absorbance maxima of Levocetrizine Hydrochloride (232nm) and absorbance maxima of Ambroxol Hydrochloride (244.5nm) were selected as λ1 and λ2 respectively. The concentrations of solutions were scanned over the range of 400nm to 200nm and absorbance at 232nm and 244.5 nm were measured. Both of these drugs obeyed Beer-Lambert’s law in the concentration range of 0–50 μg/mL for Ambroxol Hydrochloride and 0–50 μg/mL for Levocetrizine Hydrochloride. The high values of correlation coefficient (R) indicated good linearity of calibration plot for the drugs. Based on the results obtained, it can be concluded that the method is rapid, economical, accurate, precise, and reproducible. Hence, the proposed method can be employed for quantitative estimation of Ambroxol Hydrochloride and levocetirizine Hydrochloride from their tablet dosage form.

Keywords: Spectrophotometer, Dissolution, Validation, Ambroxol Hydrochloride, Levocetrizine Hydrochloride.