Разработка методик контроля качества комбинированных глазных капель антиглаукомного действия

Abstract

Одним из перспективных направле- ний современной фармацевтичес- кой науки в области создания гипо- тензивных лекарственных средств является комбинирование ЛС, вли- яющих на различные звенья патоге- неза глаукомы, что приводит к бо- лее выраженному снижению внутри- глазного давления.

A set of quality attributes and their acceptance criteria have been substantiated for the combined eye drops based on timolol maleate and taurine. It have been developed their analytical control methods that allows controlling eye drops quality in research process at the pharmaceutical development. HPLC method was proposed for the tests of Identification, Related Substances and Assay for timolol maleate, taurine and benzalconium chloride. The validation characteristics for developed control methods have been provided. Based on the test results, specifications and quality control methods for the combined eye drops having anti-glaucomatous action have been developed in accordance with the requirements of State Pharmacopoeia of Ukraine to ophthalmological drug products. The project of quality control methods have been recommended for the tests and quality control of the drug during next stages of product lifecycle.