RP-HPLC-Validated Method for Hesperidin Estimation in Rat Skin Following Transdermal Delivery via Dissolving...

Area of Science:

• Pharmaceutical Sciences
• Analytical Chemistry
• Drug Delivery Systems

Background:

• Hydroxyethyl Starch (HES) is a key component in advanced drug delivery systems.
• Dissolving microneedle patches (DMNs) offer enhanced transdermal delivery potential.
• Accurate quantification of HES is crucial for validating DMN efficacy.

Purpose of the Study:

• To develop and validate a novel reverse-phase high-performance liquid chromatography (RP-HPLC) method for HES quantification.
• To assess the method's suitability for HES-based nanostructured lipid carriers (HES-NLCs) in DMNs.
• To evaluate the transdermal permeation enhancement of HES using DMNs.

Main Methods:

• RP-HPLC method development and validation following ICH guidelines.
• Mobile phase: methanol:water (90:10 v/v), flow rate: 0.5 mL/min, UV detection at 284 nm.
• In vitro permeation studies using rat plasma and skin homogenate, comparing DMNs to passive diffusion.

Main Results:

• The RP-HPLC method demonstrated high accuracy (94-108%), precision (2%), selectivity, sensitivity, and stability.
• No interference was observed in biological matrices (rat plasma and skin homogenate).
• DMNs significantly enhanced HES transdermal permeation, showing a nearly 20-fold increase in drug deposition and higher flux and permeability coefficients compared to passive diffusion.

Conclusions:

• A validated RP-HPLC method is established for accurate HES quantification in DMNs.
• The developed method is suitable for transdermal application studies and aligns with regulatory guidelines.
• DMNs represent a promising strategy for improving transdermal drug delivery of HES.