Uminska K. Development of methods for quality control and stability determination of combined extemporal ointments with plant origin components.

Objects – combined compounding ointments with Calendula, Eucalyptus tinctures and menthol; aim – selection, development and validation of the methods for identification and quantitative determination of active pharmaceutical ingredients of compounding ointments with Calendula, Eucalyptus tinctures and menthol for the further study of their stability, and ointments quality control according to the requirements of the SPhU article “Semisolid compounding dosage forms”; methods – gas chromatography (headspace analysis, GC-MS, GC-FID), absorption spectrophotometry in the UV region, titrimetry (complexometric titration), pour-plate and double-layer inoculation methods (for microbiological purity evaluation), statistical analysis of a chemical experiment results, validation of analytical methods; novelty – the methods of biologically active components identification in the ointments with Calendula and Eucalyptus tinctures by headspace analysis and GC-MS methods were developed for the first time, the methods of 1,8-cineole in the ointment with Eucalyptus tincture and menthol in the Simanovsky ointment (Ukraine patent for utility model № 126228) quantitative determination by GC-FID were developed and validated according to the SPhU requirements, verification of methods for quantitative determination of phenylephrine hydrochloride by absorption spectrophotometry method in the UV region and zinc oxide by complexometry method in the Simanovsky ointment was done, an estimation of microbiological purity and the rheological parameters preservation of the studied ointments during one month storage at a temperature of 5 ± 3 0С was done, the physical and chemical stability of the Simanovsky ointment for a month during storage at a temperature of 5 ± 3 0С was done; results – markers for the ointments with Calendula and Eucalyptus tinctures stability studies by the headspace analysis and GC-MS were defined, methods for 1,8-cineole and menthol quantitative determination by the GC-FID were developed and validated, methods for phenylephrine hydrochloride and zinc oxide quantitative determination in the Simanovsky ointment were verified, the optimal conditions for sample preparation during the ointments stability studies and their quality control were selected, the ointments microbiological purity and their rheological parameters were evaluated within 30 days, the possibility of the Simanovsky ointment shelf life increasing from 10 to 30 days has been proved; introduced – into the practical work of the State Drugs and Medications Control Service and compounding pharmacies in various regions of Ukraine, into the scientific and pedagogical process of higher educational institutions; branch – pharmacy.