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

Document Type

Article

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.