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Quantifying alpha arbutin and niacinamide from nanocosmeceutical formulation matrix: AQbD driven high-performance
Mrunali Patel1, Vishwa Kotak2, Rashmin Patel2
1Department of Pharmaceutics and Pharmaceutical Technology, Ramanbhai Patel College of Pharmacy, Charotar University of Science and Technology (CHARUSAT), Anand, Gujarat, India.
Drug Development and Industrial Pharmacy
|July 24, 2025
Summary
A new High-Performance Thin-Layer Chromatography (HPTLC) method accurately quantifies alpha arbutin and niacinamide in nanocosmeceuticals. This validated technique ensures reliable quality control for advanced skincare formulations.
Area of Science:
- Analytical Chemistry
- Cosmetic Science
- Pharmaceutical Analysis
Background:
- Alpha arbutin and niacinamide are key ingredients in advanced skincare, valued for their therapeutic and aesthetic benefits.
- Their combined use offers a comprehensive approach to addressing various skin concerns.
- Nanocosmeceutical formulations enhance the delivery and efficacy of these active compounds.
Purpose of the Study:
- To develop and validate a robust High-Performance Thin-Layer Chromatography (HPTLC) method for quantifying alpha arbutin and niacinamide.
- To implement risk assessment and Analytical Quality by Design (AQbD) principles in method development.
- To ensure the reliable analysis of these active ingredients in nanocosmeceutical products.
Main Methods:
- Utilized Plackett-Burman and central composite designs for screening and optimizing critical method parameters.
- Employed HPTLC with specific silica gel plates and an optimized isocratic mobile phase (ethyl acetate: methanol: water).
- Validated the method according to ICHQ2(R2) guidelines, assessing specificity, linearity, sensitivity, accuracy, precision, and robustness.
Main Results:
- The HPTLC method achieved distinct retardation factors for alpha arbutin (0.31 ± 0.02) and niacinamide (0.42 ± 0.02).
- Demonstrated high specificity (peak purity ≥ 0.999) and linearity over the tested concentration ranges.
- Validation confirmed the method's sensitivity, accuracy, precision, and robustness.
Conclusions:
- A robust and validated HPTLC method was successfully developed for analyzing alpha arbutin and niacinamide.
- The method is suitable for sustainable quality control testing of nanocosmeceutical formulations.
- This analytical approach supports the reliable production of effective skincare products.
