Stability of the tranquilizer drug propionylpromazine hydrochloride in formulated products.
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 degrees 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 degrees C for 6 to 12 months, reformulation with the anti-oxidant ascorbic acid was utilized to achieve the required PPZHCl stability.
Primus
Thomas M
TM
USDA/APHIS/National Wildlife Research Center, Analytical Chemistry Project, 4101 LaPorte Avenue, Ft Collins, CO 80521, USA. thomas.m.primus@aphis.usda.gov
Kimball
Bruce A
BA
Hurley
Jerome
J
Johnston
John J
JJ
Blom
Sherm
S
Savarie
Peter J
PJ
D000818:Animals; D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D006993:Hypnotics and Sedatives / Q000008:administration & dosage / Q000737:chemistry*; D013058:Mass Spectrometry; D015394:Molecular Structure; D011395:Promazine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000737:chemistry*
D006993:Hypnotics and Sedatives; D011395:Promazine; C026328:propionylpromazine