Čes. slov. farm. 2004, 53(4):187-191

A Study of the Stability of Dioxopromethazine by HPLC Method

Z. Capková¹, T. Hudecová², Š. Hatrík², E. Havránek², Z. Vitková¹

¹ Katedra galenickej farmácie Farmaceutickej fakulty Univerzity Komenského, Bratislava

² Katedra farmaceutickej analýzy a nukleárnej farmácie Farmaceutickej fakulty UniverzityKomenského, Bratislava

Dioxopromethazine began to be used in therapy as a modern antihistamine agent in the 1970s.A dioxopromethazine-containing ophthalmic instillation and a gel were employed until the end ofthe 1990s. The paper deals with the examination of the stability of the drug dioxopromethazine inaqueous solutions and the ophthalmic instillation Promefrin® stored under different conditions.High-performance liquid chromatography with spectrophotometrical and electrochemical detectionand HPLC connected on-line with mass spectrometry were employed for analysis. Dioxopromethazinein aqueous solutions and in ophthalmic instillations stored in direct sunlight was found not tobe stable. However, the cover of the ophthalmic instillation, a brown-glass prescription bottle, andobservation of storing conditions sufficiently protect the active ingredient from decompositionprocesses.

Keywords: dioxopromethazine; Promefrin®; stability; HPLC

Published: April 1, 2004  Show citation