Stability of the tranquilizer drug propionylpromazine hydrochloride in formulated products

Authors

Thomas M. Primus, USDA/APHIS/WS National Wildlife Research Center, Analytical Chemistry Project
Bruce A. Kimball, USDA/APHIS/WS National Wildlife Research CenterFollow
Jerome Hurley, USDA/APHIS/WS National Wildlife Research Center, Analytical Chemistry Project
John J. Johnston, USDA/APHIS/WS National Wildlife Research Center, Analytical Chemistry ProjectFollow
Sherm Blom, USDA/APHIS/WS National Wildlife Research Center, Analytical Chemistry Project
Peter J. Savarie, USDA/APHIS/WS National Wildlife Research Center, Analytical Chemistry Project

Date of this Version

January 2005

Abstract

An analytical method to evaluate propionylpromazine hydrochloride (PPZHCl) in tranquilizer formulations was developed using high-performance liquid chromatography (HPLC). During analysis of aged quality-control samples, a previously unreported chromatographic response was observed at a shorter retention time than PPZHCl. Further investigation of formulations stored in trap tap devices at temperatures ranging from 5 to 40 ◦C during field trials at four different locations confirmed the degradation of the active ingredient. Further investigation using HPLC/tandem mass spectrometry revealed two to five degradates, with the major degradates being oxidation products of the active ingredient, PPZHCl. As PPZHCl formulations must be stable when stored at 5 to 40 ◦C for 6 to 12months, reformulation with the anti-oxidant ascorbic acid was utilized to achieve the required PPZHCl stability. Published in 2005 for SCI by John Wiley & Sons, Ltd.