P. J. Palermo
1987
Citations
0
Influential Citations
1
Citations
Journal
Journal of pharmaceutical and biomedical analysis
Abstract
The local anaesthetic properties of dyclonine hydrochloride, 1-(4-butoxyphenyl)-3-(lpiperidinyl)-1-propanone have been known for some time [l]. Its use in a lozenge formulation has also been described [2]. Yet there is a paucity of analytical procedures for this drug reported in the literature. Thin layer chromatographic (TLC) systems [3,4] and a gas chromatographic (GC) system [5] have been presented but without quantitation. Polarographic characterization procedures [6,7] have also been presented. No decomposition studies or stability results for dyclonine have been reported. Analytical methodology was required to assess the stability of dyclonine hydrochloride and determine its degradation route and products in pharmaceutical preparations used as cough lozenges and syrups. Both GC and high pressure liquid chromatographic (HPLC) approaches were investigated and found feasible. However, the GC approach necessitated pH sensitive extractions as the free base prior to injection. This paper presents HPLC systems and procedures developed for monitoring the stability of dyclonine hydrochloride in formulations and the results of the stability studies. In addition, the structures of some of the probable degradation products have been elucidated and described herein.