Stability studies of isohydrafural and fluocinolone acetonide combined ointment
Background: The isohydrafural and fluocinolone acetonide combined ointment contributes to the diversification of the treatment of dermatitis and psoriasis associated with bacterial infections. Complex stability studies were performed to ensure the quality of it during the shelf life. The objective...
| Main Authors: | , , |
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| Format: | Article |
| Language: | English |
| Published: |
Scientific Medical Association of Moldova
2020-10-01
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| Series: | The Moldovan Medical Journal |
| Subjects: | |
| Online Access: | http://moldmedjournal.md/wp-content/uploads/2020/09/moldovan-med-j-2020-63-4-donici-full-text.pdf |
| _version_ | 1819205304903008256 |
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| author | Elena Donici Vladimir Valica Livia Uncu |
| author_facet | Elena Donici Vladimir Valica Livia Uncu |
| author_sort | Elena Donici |
| collection | DOAJ |
| description | Background: The isohydrafural and fluocinolone acetonide combined ointment contributes to the diversification of the treatment of dermatitis and
psoriasis associated with bacterial infections. Complex stability studies were performed to ensure the quality of it during the shelf life. The objective of
this study was to determine the stability and shelf life of the combined ointment containing isohydrafural and fluocinolone acetonide.
Material and methods: Three series of ointment were tested by the real-time method (temperature 25± 2°C; relative humidity 60 ± 5%) over a period
of 30 months, periodically determining the appearance, homogeneity, pH, viscosity, identity, purity and assay. OHAUS DV215 CD electronic balance,
Shimadzu LC-20 A HPLC, Consort C861 pH meter and Fungilab rheometer were used to fulfil the study.
Results: At 24 months after storage, the three series of the ointment proved to be homogeneous, with a pH between 5.76 and 5.53. The rheograms showed
a pseudoplastic behavior, with a slight thixotropy, with a viscosity close to 70 cP. The active substances were detected at the characteristic retention times:
isohydrafural – 3 minutes, fluocinolone acetonide – 5.9 minutes and also no additional peaks occurred. The content of active substances was within the
permitted limits: 0.098-0.11% (m/m) for isohydrafural and 0.0248-0.025% (m/m) for fluocinolone acetonide.
Conclusions: The combined ointment containing isohydrafural and fluocinolone acetonide was found to be stable under the storage conditions stipulated
in the quality specification. The established shelf life is 24 months. |
| first_indexed | 2024-12-23T04:49:35Z |
| format | Article |
| id | doaj.art-49371cf92b26430f8464cea87c17753a |
| institution | Directory Open Access Journal |
| issn | 2537-6373 2537-6381 |
| language | English |
| last_indexed | 2024-12-23T04:49:35Z |
| publishDate | 2020-10-01 |
| publisher | Scientific Medical Association of Moldova |
| record_format | Article |
| series | The Moldovan Medical Journal |
| spelling | doaj.art-49371cf92b26430f8464cea87c17753a2022-12-21T17:59:31ZengScientific Medical Association of MoldovaThe Moldovan Medical Journal2537-63732537-63812020-10-01634121710.5281/zenodo.4016802Stability studies of isohydrafural and fluocinolone acetonide combined ointmentElena Donici0https://orcid.org/0000-0001-6862-7449Vladimir Valica1https://orcid.org/0000-0002-1068-5504Livia Uncu2https://orcid.org/0000-0003-3453-2243Department of Pharmaceutical and Toxicological Chemistry, Nicolae Testemitanu State University of Medicine and Pharmacy, Chisinau, the Republic of MoldovaDepartment of Pharmaceutical and Toxicological Chemistry, Nicolae Testemitanu State University of Medicine and Pharmacy, Chisinau, the Republic of MoldovaDepartment of Pharmaceutical and Toxicological Chemistry, Nicolae Testemitanu State University of Medicine and Pharmacy, Chisinau, the Republic of MoldovaBackground: The isohydrafural and fluocinolone acetonide combined ointment contributes to the diversification of the treatment of dermatitis and psoriasis associated with bacterial infections. Complex stability studies were performed to ensure the quality of it during the shelf life. The objective of this study was to determine the stability and shelf life of the combined ointment containing isohydrafural and fluocinolone acetonide. Material and methods: Three series of ointment were tested by the real-time method (temperature 25± 2°C; relative humidity 60 ± 5%) over a period of 30 months, periodically determining the appearance, homogeneity, pH, viscosity, identity, purity and assay. OHAUS DV215 CD electronic balance, Shimadzu LC-20 A HPLC, Consort C861 pH meter and Fungilab rheometer were used to fulfil the study. Results: At 24 months after storage, the three series of the ointment proved to be homogeneous, with a pH between 5.76 and 5.53. The rheograms showed a pseudoplastic behavior, with a slight thixotropy, with a viscosity close to 70 cP. The active substances were detected at the characteristic retention times: isohydrafural – 3 minutes, fluocinolone acetonide – 5.9 minutes and also no additional peaks occurred. The content of active substances was within the permitted limits: 0.098-0.11% (m/m) for isohydrafural and 0.0248-0.025% (m/m) for fluocinolone acetonide. Conclusions: The combined ointment containing isohydrafural and fluocinolone acetonide was found to be stable under the storage conditions stipulated in the quality specification. The established shelf life is 24 months.http://moldmedjournal.md/wp-content/uploads/2020/09/moldovan-med-j-2020-63-4-donici-full-text.pdfсombined ointmentstabilityshelf life |
| spellingShingle | Elena Donici Vladimir Valica Livia Uncu Stability studies of isohydrafural and fluocinolone acetonide combined ointment The Moldovan Medical Journal сombined ointment stability shelf life |
| title | Stability studies of isohydrafural and fluocinolone acetonide combined ointment |
| title_full | Stability studies of isohydrafural and fluocinolone acetonide combined ointment |
| title_fullStr | Stability studies of isohydrafural and fluocinolone acetonide combined ointment |
| title_full_unstemmed | Stability studies of isohydrafural and fluocinolone acetonide combined ointment |
| title_short | Stability studies of isohydrafural and fluocinolone acetonide combined ointment |
| title_sort | stability studies of isohydrafural and fluocinolone acetonide combined ointment |
| topic | сombined ointment stability shelf life |
| url | http://moldmedjournal.md/wp-content/uploads/2020/09/moldovan-med-j-2020-63-4-donici-full-text.pdf |
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