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Title: Fast Screening Methods for the Analysis of Topical Drug Products
Authors: Miranda, Margarida 
Cardoso, Catarina
Vitorino, Carla 
Keywords: RP-HPLC; Topical products; Semi-solid dosage forms; Validation
Issue Date: 2020
Publisher: MDPI
Project: PD/BDE/135075/2017 
PEst- OE/QUI/UI0313/2014 
Serial title, monograph or event: Processes
Volume: 8
Issue: 4
Abstract: 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
ISSN: 2227-9717
DOI: 10.3390/pr8040397
Rights: openAccess
Appears in Collections:I&D CQC - Artigos em Revistas Internacionais

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