TY - JOUR
T1 - Fast screening methods for the analysis of topical drug products
AU - Miranda, Margarida
AU - Cardoso, Catarina
AU - Vitorino, Carla
N1 - Publisher Copyright:
© 2020 by the authors.
PY - 2020/4/1
Y1 - 2020/4/1
N2 - 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™s C18 (5 μm particle size, 150 mm × 2.1 mm), or alternatively on a LiChrospher® 100 RP-18 (5 μmparticle 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, 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.
AB - 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™s C18 (5 μm particle size, 150 mm × 2.1 mm), or alternatively on a LiChrospher® 100 RP-18 (5 μmparticle 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, 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.
KW - RP-HPLC
KW - Semi-solid dosage forms
KW - Topical products
KW - Validation
UR - http://www.scopus.com/inward/record.url?scp=85086720355&partnerID=8YFLogxK
U2 - 10.3390/PR8040397
DO - 10.3390/PR8040397
M3 - Article
AN - SCOPUS:85086720355
SN - 2227-9717
VL - 8
JO - Processes
JF - Processes
IS - 4
M1 - 397
ER -