LAPSE:2020.0549
Published Article
LAPSE:2020.0549
Fast Screening Methods for the Analysis of Topical Drug Products
Margarida Miranda, Catarina Cardoso, Carla Vitorino
June 10, 2020
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 µm particle size, 150 mm × 2.1 mm), or alternatively on a LiChrospher® 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.
Keywords
RP-HPLC, semi-solid dosage forms, topical products, validation
Suggested Citation
Miranda M, Cardoso C, Vitorino C. Fast Screening Methods for the Analysis of Topical Drug Products. (2020). LAPSE:2020.0549
Author Affiliations
Miranda M: Faculty of Pharmacy, University of Coimbra, Pólo das Ciências da Saúde, Azinhaga de Santa Comba, 3000-548 Coimbra, Portugal; Coimbra Chemistry Center, Department of Chemistry, University of Coimbra, Rua Larga, 3004-535 Coimbra, Portugal
Cardoso C: Laboratórios Basi, Parque Industrial Manuel Lourenço Ferreira, lote 15, 3450-232 Mortágua, Portugal
Vitorino C: Faculty of Pharmacy, University of Coimbra, Pólo das Ciências da Saúde, Azinhaga de Santa Comba, 3000-548 Coimbra, Portugal; Coimbra Chemistry Center, Department of Chemistry, University of Coimbra, Rua Larga, 3004-535 Coimbra, Portugal; Centre for Neu
Journal Name
Processes
Volume
8
Issue
4
Article Number
E397
Year
2020
Publication Date
2020-03-29
Published Version
ISSN
2227-9717
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Original Submission
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PII: pr8040397, Publication Type: Journal Article
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LAPSE:2020.0549
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doi:10.3390/pr8040397
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Jun 10, 2020
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Jun 10, 2020
 
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Calvin Tsay
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