Chemical stability estimation of the deflagilic ointment
| Author | Affiliation |
|---|---|
Savchenko, Lesia Petrivna | |
| Date |
|---|
2019-04-13 |
ISBN 978-9955-9568-4-6.
Bibliogr.: p. 17
Introduction. The tendency of compounding medicines preparation in Ukraine is changing today. Preparation often held in the main compounding pharmacy of the network, and then medicines transmitted to other pharmacies. A big problem for such compounding pharmacies is the rather limited shelf life (only 10 days according to the State Pharmacopoeia of Ukraine (SPhU) article «Non-sterile compounding medicines» requirements). Often, medicines that are prepared for stock may remain stable over a longer period, but the shelf life increasing is possible only if there is scientifically confirmed information on studying the stability of the dosage form over a certain period. One of the compounding ointments that is prepared for stock in the pharmacies of Ukraine is deflagilic ointment (sodium thiosulfate 5.0; urea 5.0; water purified 3.0 ml; paraffin liquid 10.0; wool fat 10.0). It is applied externally for the treatment of sinusitis. The aim of our work was to assess the ointment chemical stability during certain storage period to determine the possibility of its shelf life extending. Materials and Methods. Three ointment samples from three different series prepared in the same pharmacy were selected for studies. The samples were stored at a temperature of 5±3 0С and relative humidity 60-65 %. Measured glassware of class A, reagents and volumetric solutions which correspond to the SPhU requirements, analytical balance AXIS ANG 200 (Poland), spectrophotometer Evolution 60S (USA) were used for the work. Ointment active ingredients quantitative content determination was carried out in a freshly prepared ointment, and then every next 30 days of storage (on the 60th, 90th, 120th and 105th day). Results and discussion. Sodii thiosulfate quantitative determination was done by the iodometric titration method (by the SPhU article recommendations). For the urea quantitative determination spectrophotometric method was developed. Since there is no description of the develope