Fast Screening Methods for the Analysis of Topical Drug Products
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...
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doaj-5592b94637d0419a91bba941c33b2b652020-11-25T02:04:01ZengMDPI AGProcesses2227-97172020-03-01839739710.3390/pr8040397Fast Screening Methods for the Analysis of Topical Drug ProductsMargarida Miranda0Catarina Cardoso1Carla Vitorino2Faculty of Pharmacy, University of Coimbra, Pólo das Ciências da Saúde, Azinhaga de Santa Comba, 3000-548 Coimbra, PortugalLaboratórios Basi, Parque Industrial Manuel Lourenço Ferreira, lote 15, 3450-232 Mortágua, PortugalFaculty of Pharmacy, University of Coimbra, Pólo das Ciências da Saúde, Azinhaga de Santa Comba, 3000-548 Coimbra, PortugalConsidering 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 XBridge<sup>TM</sup> C18 (5 µm particle size, 150 mm × 2.1 mm), or alternatively on a LiChrospher<sup>®</sup> 100 RP-18 (5 µm particle size, 125 mm × 4.6 mm) at 30 °C, under isocratic conditions using UV detection at specific wavelengths. According to the physicochemical characteristics of each drug, different 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.https://www.mdpi.com/2227-9717/8/4/397RP-HPLCtopical productssemi-solid dosage formsvalidation |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Margarida Miranda Catarina Cardoso Carla Vitorino |
spellingShingle |
Margarida Miranda Catarina Cardoso Carla Vitorino Fast Screening Methods for the Analysis of Topical Drug Products Processes RP-HPLC topical products semi-solid dosage forms validation |
author_facet |
Margarida Miranda Catarina Cardoso Carla Vitorino |
author_sort |
Margarida Miranda |
title |
Fast Screening Methods for the Analysis of Topical Drug Products |
title_short |
Fast Screening Methods for the Analysis of Topical Drug Products |
title_full |
Fast Screening Methods for the Analysis of Topical Drug Products |
title_fullStr |
Fast Screening Methods for the Analysis of Topical Drug Products |
title_full_unstemmed |
Fast Screening Methods for the Analysis of Topical Drug Products |
title_sort |
fast screening methods for the analysis of topical drug products |
publisher |
MDPI AG |
series |
Processes |
issn |
2227-9717 |
publishDate |
2020-03-01 |
description |
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 XBridge<sup>TM</sup> C18 (5 µm particle size, 150 mm × 2.1 mm), or alternatively on a LiChrospher<sup>®</sup> 100 RP-18 (5 µm particle size, 125 mm × 4.6 mm) at 30 °C, under isocratic conditions using UV detection at specific wavelengths. According to the physicochemical characteristics of each drug, different 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. |
topic |
RP-HPLC topical products semi-solid dosage forms validation |
url |
https://www.mdpi.com/2227-9717/8/4/397 |
work_keys_str_mv |
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