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HSPiP and QbD Program-Based Analytical Method Development and Validation to Quantify Ketoconazole in Dermatokinetic

Afzal Hussain1, Mohhammad Ramzan2, Mohammad A Altamimi3

  • 1Department of Pharmaceutics, College of Pharmacy, King Saud University, 11451, Riyadh, Saudi Arabia. amohammed2@ksu.edu.sa.

AAPS Pharmscitech
|November 14, 2023
PubMed
Summary
This summary is machine-generated.

A new analytical method accurately quantifies ketoconazole (KTZ) in rat skin. This method uses Hansen solubility parameters and high-performance liquid chromatography for reliable antifungal drug analysis.

Keywords:
HPLCHansen solubility parameters (HSPiP software)Taguchi model and surface response methodologydermatokinetics of KTZ-SLNsketoconazole

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Area of Science:

  • Analytical Chemistry
  • Pharmacokinetics
  • Dermatology

Background:

  • Ketoconazole (KTZ) is a key azole antifungal agent.
  • Accurate quantification of KTZ in skin layers post-topical application is crucial for efficacy assessment.
  • Current methods may lack sensitivity, specificity, or efficiency for complex matrices like skin homogenates.

Purpose of the Study:

  • To develop and validate a sensitive, specific, rapid, reproducible, and economical bioanalytical method for KTZ quantification in treated rat skin homogenates.
  • To utilize Hansen solubility parameters (HSP) and experimental design for optimizing the analytical method, specifically the high-performance liquid chromatography (HPLC) mobile phase.
  • To assess KTZ quantification in various formulations, including nanocarriers, extracted from rat skin.

Main Methods:

  • Hansen solubility parameter (HSP) modeling using HSPiP software to predict optimal solvents for KTZ.
  • Taguchi experimental design to identify significant factors (acetonitrile concentration, mobile phase pH) for method optimization.
  • High-performance liquid chromatography (HPLC) method validation according to US-FDA guidelines.
  • Surface response methodology (SRM) to analyze the impact of ACN concentration and pH on peak area and retention time.

Main Results:

  • HSP values guided the selection of mobile phase solvents, with maximum experimental solubility observed in acetonitrile (ACN) and ethyl acetate.
  • ACN concentration and mobile phase pH were identified as critical factors significantly impacting HPLC peak area and retention time.
  • Validated analytical limits were established (0.17 and 0.50 µg/mL for KTZ-SLNs extracted from skin).
  • The developed method demonstrated high reproducibility, accuracy, and selectivity for quantifying KTZ in treated rat skin.

Conclusions:

  • A robust and efficient HPLC method, optimized using HSP and experimental design, enables accurate KTZ quantification in rat skin.
  • The method is suitable for analyzing KTZ from various topical formulations, including nanocarrier-based systems, extracted from skin.
  • This validated bioanalytical approach supports pharmacokinetic studies and formulation development for topical antifungal treatments.