AQbD-Guided Development and Validation of RP-HPLC Method for Quantitative Estimation of Remogliflozin

Transdermal drug delivery systems (TDDS) have the potential to be a superior alternative to
conventional drug delivery as they deliver the drug across the skin into the bloodstream
bypassing gastrointestinal degradation and first-pass metabolism. The aim of the present work
was to formulate and evaluate a polymer-based film forming gel system containing
clotrimazole and beclomethasone dipropionate to treat fungal skin infections associated with
inflammation. Clotrimazole acts as a broad-spectrum antifungal agent by inhibiting fungal cell
membrane synthesis, while beclomethasone dipropionate provides anti-inflammatory action by
regulating glucocorticoid receptor-mediated gene transcription. Preformulation studies,
including organoleptic evaluation, melting point determination, solubility studies, calibration
curve, and FTIR analysis, were performed to assess drug characteristics and compatibility with
excipients. Film-forming gels were prepared using HPMC E4M, Kollidon VA64, Sepineo
D.E.R.M, propylene glycol, methyl paraben, and ethanol through a solvent evaporation
technique, producing nine formulations (F1–F9) with varying polymer concentrations. All
formulations were analyzed for physical characteristics, pH, viscosity, spreadability, drying
time, drug content and in-vitro drug release studies by using a Franz diffusion cell with
cellophane membrane in phosphate buffer pH 5.5. All formulations showed clear to slightly
translucent appearance with homogeneous and smooth spread. The values of pH were in
between 5.7-6.2 and suitable for topical application. With increased concentration of HPMC
(4220±126 to 6550±131cP) viscosity was increased and spreadability was found to be
decreased. Drying time was found to be nearly within 4-7 min suitable for film forming
formulation. Drug content was found between 85.49–97.65% for clotrimazole and 88.15–
98.10% for beclomethasone dipropionate, demonstrating uniform drug distribution. In vitro
drug release studies showed sustained release profiles, with clotrimazole release ranging from
78.87–96.50% and beclomethasone dipropionate from 75.22–93.25% over 10 hours, with
formulation F6 showing the highest drug release.