Validation of high-performance liquid chromatographic method for analysis of fluconazole in microemulsions and liquid crystals
In recent decades, there has been a significant increase in the incidence of fungal diseases. Certain fungal diseases cause cutaneous lesions and in the usual treatment, generally administred orally, the drug reaches the site of action with difficulty and its concentration is too low. An approach mu...
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| Format: | Article |
| Language: | English |
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Universidade de São Paulo
2014-04-01
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| Series: | Brazilian Journal of Pharmaceutical Sciences |
| Subjects: | |
| Online Access: | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502014000200381&lng=en&tlng=en |
| _version_ | 1818354165676507136 |
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| author | Hilris Rocha e Silva Fernanda Kolenyak dos Santos Gabriela Marielli da Luz Marlus Chorilli Maria Palmira Daflon Gremião |
| author_facet | Hilris Rocha e Silva Fernanda Kolenyak dos Santos Gabriela Marielli da Luz Marlus Chorilli Maria Palmira Daflon Gremião |
| author_sort | Hilris Rocha e Silva |
| collection | DOAJ |
| description | In recent decades, there has been a significant increase in the incidence of fungal diseases. Certain fungal diseases cause cutaneous lesions and in the usual treatment, generally administred orally, the drug reaches the site of action with difficulty and its concentration is too low. An approach much explored in recent years is the development of nanotechnology-based drug delivery systems, and microemulsions (ME) and liquid crystals (LC) are promising. ME and LC were developed with oleic acid or copaiba oil as the oil phase, propoxyl (5OP) ethoxyl (20 OE) cetyl alcohol as surfactant and water. An analytical method to assess the incorporation of fluconazole (FLU) in the systems under study was validated according to guidelines of the International Conference on Harmonization (ICH) guidelines and the Brazilian Food, Drug and Sanitation Agency (ANVISA). The method was conducted on a C18-RP column (250 × 4.6 mm i.d.), maintained at room temperature. The mobile phase consisted of acetonitrile and water (50:50, v/v), run at a flow rate of 1.0mL/min and using ultraviolet detection at 210nm. The chromatographic separation was obtained with a retention time of 6.3min, and was linear in the range of 20-400 µg/mL (r2=0.9999). The specificity showed no interference of the excipients. The accuracy was 100.76%. The limits of detection and quantitation were 0.057 and 0.172 µg.mL-1, respectively. Moreover, method validation demonstrated satisfactory results for precision and robustness. The proposed method was applied for the analysis of the incorporation of FLU in ME and LC, contributing to improve the quality control and to assure the therapeutic efficacy. |
| first_indexed | 2024-12-13T19:21:05Z |
| format | Article |
| id | doaj.art-65b9f85a50404f0fbd96bf1c0c44ea7a |
| institution | Directory Open Access Journal |
| issn | 2175-9790 |
| language | English |
| last_indexed | 2024-12-13T19:21:05Z |
| publishDate | 2014-04-01 |
| publisher | Universidade de São Paulo |
| record_format | Article |
| series | Brazilian Journal of Pharmaceutical Sciences |
| spelling | doaj.art-65b9f85a50404f0fbd96bf1c0c44ea7a2022-12-21T23:34:09ZengUniversidade de São PauloBrazilian Journal of Pharmaceutical Sciences2175-97902014-04-0150238138910.1590/S1984-82502014000200018S1984-82502014000200381Validation of high-performance liquid chromatographic method for analysis of fluconazole in microemulsions and liquid crystalsHilris Rocha e SilvaFernanda Kolenyak dos SantosGabriela Marielli da LuzMarlus ChorilliMaria Palmira Daflon GremiãoIn recent decades, there has been a significant increase in the incidence of fungal diseases. Certain fungal diseases cause cutaneous lesions and in the usual treatment, generally administred orally, the drug reaches the site of action with difficulty and its concentration is too low. An approach much explored in recent years is the development of nanotechnology-based drug delivery systems, and microemulsions (ME) and liquid crystals (LC) are promising. ME and LC were developed with oleic acid or copaiba oil as the oil phase, propoxyl (5OP) ethoxyl (20 OE) cetyl alcohol as surfactant and water. An analytical method to assess the incorporation of fluconazole (FLU) in the systems under study was validated according to guidelines of the International Conference on Harmonization (ICH) guidelines and the Brazilian Food, Drug and Sanitation Agency (ANVISA). The method was conducted on a C18-RP column (250 × 4.6 mm i.d.), maintained at room temperature. The mobile phase consisted of acetonitrile and water (50:50, v/v), run at a flow rate of 1.0mL/min and using ultraviolet detection at 210nm. The chromatographic separation was obtained with a retention time of 6.3min, and was linear in the range of 20-400 µg/mL (r2=0.9999). The specificity showed no interference of the excipients. The accuracy was 100.76%. The limits of detection and quantitation were 0.057 and 0.172 µg.mL-1, respectively. Moreover, method validation demonstrated satisfactory results for precision and robustness. The proposed method was applied for the analysis of the incorporation of FLU in ME and LC, contributing to improve the quality control and to assure the therapeutic efficacy.http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502014000200381&lng=en&tlng=enNanotecnologiaMicroemulsõesCristais líquidosCromatografia líquida de alta eficiência/análise qualitativaFluconazol |
| spellingShingle | Hilris Rocha e Silva Fernanda Kolenyak dos Santos Gabriela Marielli da Luz Marlus Chorilli Maria Palmira Daflon Gremião Validation of high-performance liquid chromatographic method for analysis of fluconazole in microemulsions and liquid crystals Brazilian Journal of Pharmaceutical Sciences Nanotecnologia Microemulsões Cristais líquidos Cromatografia líquida de alta eficiência/análise qualitativa Fluconazol |
| title | Validation of high-performance liquid chromatographic method for analysis of fluconazole in microemulsions and liquid crystals |
| title_full | Validation of high-performance liquid chromatographic method for analysis of fluconazole in microemulsions and liquid crystals |
| title_fullStr | Validation of high-performance liquid chromatographic method for analysis of fluconazole in microemulsions and liquid crystals |
| title_full_unstemmed | Validation of high-performance liquid chromatographic method for analysis of fluconazole in microemulsions and liquid crystals |
| title_short | Validation of high-performance liquid chromatographic method for analysis of fluconazole in microemulsions and liquid crystals |
| title_sort | validation of high performance liquid chromatographic method for analysis of fluconazole in microemulsions and liquid crystals |
| topic | Nanotecnologia Microemulsões Cristais líquidos Cromatografia líquida de alta eficiência/análise qualitativa Fluconazol |
| url | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502014000200381&lng=en&tlng=en |
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