An-Najah Staff

Purpose: The aim of this study is to develop bromhexine  hydrochloride 1 %w/v oral solution for veterinary use and to evaluate its  stability. Methods: Solutions of Bromhexine hydrochloride (1%w/v) were  prepared by dissolving bromhexine hydrochloride in benzyl alcohol at 50 °C  then alcohol 96 % v/v; Tween 80 and purified water were added. The obtained  solution was filled in amber glass bottles, and the solution was stored at 25  °C/60 % relative humidity (RH) and at 40 °C /75% RH. The strengths of  bromhexine hydrochloride were determined by High performance liquid  chromatographic assay at 0, 2, 4, 6, 8, 10, 12, 16, 20 and 24 months. The  concentrations of the drug were directly related to the peak area. pH, odor,  color and crystal formation was also monitored. Results: The degradation of  bromhexine hydrochloride 1% w/v oral solution was faster at 40 °C/75% RH  than at 25 °C /60% RH. No significant differences were found between the  initial and final pH value for the solution at the studied conditions. No  detectable changes in color, odor or precipitations were observed for the  solutions stored at the upper conditions. Conclusions: Bromhexine  hydrochloride 1% w/v oral solution could be formulated and remains stable  for at least 2 years when is stored at 25°C /60% RH and for 16 months when  stored at 40 °C /75% RH.