USMF logo

Institutional Repository in Medical Sciences
of Nicolae Testemitanu State University of Medicine and Pharmacy
of the Republic of Moldova
(IRMS – Nicolae Testemitanu SUMPh)

Biblioteca Stiintifica Medicala
DSpace

University homepage  |  Library homepage

 
 
Please use this identifier to cite or link to this item: http://hdl.handle.net/20.500.12710/12773
Title: Scientific Center for Drug Research besides Nicolae Testemitanu State University of Medicine and Pharmacy of Republic of Moldova
Authors: Eugeniu, Nicolai
Vîslouh, Oxana
Valica, Vladimir
Parii, Sergiu
Uncu, Livia
Keywords: stability;combined ear drops;otitis;shelf life
Issue Date: Oct-2020
Publisher: Universitatea de Stat de Medicină şi Farmacie "Nicolae Testemiţanu" din Republica Moldova
Abstract: NTRODUCTION. The stability of a drug is an important factor in ensuring its quality. The studied combined ear drops have an increased tendency of degradation, which requires an extensive stability study and obtaining data to determine the shelf life and establish the storage conditions. The purpose. Stability studies of ear drops containing ciprofloxacin, dexamethasone, loratadine and volatile basil oil. MATERIAL AND METHODS. ICH Q1A (R2) stability testing methodology; 3 series of ear drops; reference standards for the active substances (Sigma Aldrich, USA); Shimadzu LC20AD liquid chromatograph with UV-VIS detector; Fungilab Smart R viscometer; pH meter inoLab 7110; solvents, reagents in accordance with the European Pharmacopoeia. RESULTS. Ciprofloxacin is stable in acid medium, degrades in alkaline medium after 3 hours (approximately 10.0%), under oxidation (19.7%) and light action (17.1%). Dexamethasone degrades in acid medium (by 7.7%) and under oxidation (by 19.9%), it is stable in alkaline medium and under the action of light. Loratadine degrades in acid medium (by 3.0%), is stable in alkaline medium, under oxidation and action of light. In real-time storage conditions (25°C±2°C and RH 60%±5%), it was found that the pharmaceutical form did not change its quality parameters for 24 months. CONCLUSIONS. The stability studies under stress and in real time conditions allowed us to select the packaging, the optimal storage conditions and to establish the provisional shelf life for the combined auricular pharmaceutical form during 2 years.
URI: http://repository.usmf.md/handle/20.500.12710/12773
https://stiinta.usmf.md/ro/manifestari-stiintifice/zilele-universitatii
Appears in Collections:Culegere de postere



Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.

 

Valid XHTML 1.0! DSpace Software Copyright © 2002-2013  Duraspace - Feedback