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https://hdl.handle.net/10316/106640
Título: | Fast Screening Methods for the Analysis of Topical Drug Products | Autor: | Miranda, Margarida Cardoso, Catarina Vitorino, Carla |
Palavras-chave: | RP-HPLC; topical products; semi-solid dosage forms; validation | Data: | 2020 | Editora: | MDPI | Projeto: | FCT (Fundação para a Ciência e a Tecnologia, Portugal) and Laboratórios Basi from Drugs R&D Doctoral Program PhD PD/BDE/135075/2017 PEst-OE/QUI/UI0313/2014 POCI-01-0145-FEDER-007630 |
Título da revista, periódico, livro ou evento: | Processes | Volume: | 8 | Número: | 4 | Resumo: | Considering the recent regulatory requirements, the overall importance of in vitro release testing (IVRT) methods regarding topical product development is undeniable, especially when addressing particulate systems. For each IVRT study, several hundreds of samples are generated. Therefore, developing rapid reversed-phase high-performance liquid chromatography (RP-HPLC) methods, able to provide a real-time drug analysis of IVRT samples, is a priority. In this study, eight topical complex drug products exhibiting distinct physicochemical profiles were considered. RP-HPLC methods were developed and fully validated. Chromatographic separations were achieved on a XBridgeTM C18 (5 m particle size, 150 mm 2.1 mm), or alternatively on a LiChrospher® 100 RP-18 (5 mparticle size, 125mm 4.6 mm) at 30 C, under isocratic conditions using UV detection at specific wavelengths. According to the physicochemical characteristics of each drug, di erent mobile phases were selected. Irrespective of the drug (hydrocortisone, etofenamate, bifonazole, clotrimazole, acyclovir, tioconazole, clobetasol, and diclofenac) and formulation, retention time values did not exceed 6.5 min. All methods were linear, specific, precise, and accurate at the intraday and interday levels, robust, and stable. These were successfully applied to establish product-specific IVRT profiles, thus providing a key database useful for topical pharmaceutical manufacturers. | URI: | https://hdl.handle.net/10316/106640 | ISSN: | 2227-9717 | DOI: | 10.3390/pr8040397 | Direitos: | openAccess |
Aparece nas coleções: | FFUC- Artigos em Revistas Internacionais I&D CQC - Artigos em Revistas Internacionais |
Ficheiros deste registo:
Ficheiro | Descrição | Tamanho | Formato | |
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Fast-screening-methods-for-the-analysis-of-topical-drug-productsProcesses.pdf | 1.48 MB | Adobe PDF | Ver/Abrir |
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