Drug development and industrial pharmacy · 2025
Quantifying alpha arbutin and niacinamide from nanocosmeceutical formulation matrix: AQbD driven high-performance thin-layer chromatographic method.
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Patel Mrunali, Kotak Vishwa, Patel Rashmin
Аннотация
BACKGROUND: The combined therapy of alpha arbutin, a natural derivative of hydroquinone, and niacinamide is well-regarded in skincare science. It leverages the unique properties of both actives, providing a multifaceted solution to esthetic and therapeutic skin concerns and supporting a comprehensive approach to skincare.
OBJECTIVE: This study aimed to develop a robust HPTLC method to determine alpha arbutin and niacinamide in a nanocosmeceutical using a comprehensive approach that includes risk assessment and Analytical Quality by Design.
METHODS: The critical method parameters influencing the HPTLC results were screened using a Plackett-Burman screening design, followed by optimization using a central composite optimization design and validation of the optimized method as per ICHQ2(R2).
RESULTS: A novel HPTLC utilized pre-coated aluminum-backed HPTLC plates of Silica gel G 60 F254 using 10 µL/band injection volume, and the plate was developed using an isocratic mobile phase consisting of ethyl acetate: methanol: water (8.4:0.8:0.8v/v/v) in a twin trough chamber pre-saturated for 30 mins with vapors of 10 mL of mobile phase. The separated components were detected at a wavelength of 273 nm. The developed HPTLC method resulted in a retardation factor of 0.31 ± 0.02 for alpha arbutin and 0.42 ± 0.02 for niacinamide, respectively. Validation results revealed the HPTLC method's specificity (peak purity ≥ 0.999), linearity (over a studied concentration range of 200-800 ng/band for alpha arbutin and 400-1600 ng/band for niacinamide), sensitivity, accuracy, precision, and robustness.
CONCLUSION: The developed robust HPTLC method was successfully implemented for the sustainable testing of the alpha arbutin and niacinamide in the nanocosmeceutical formulations.
OBJECTIVE: This study aimed to develop a robust HPTLC method to determine alpha arbutin and niacinamide in a nanocosmeceutical using a comprehensive approach that includes risk assessment and Analytical Quality by Design.
METHODS: The critical method parameters influencing the HPTLC results were screened using a Plackett-Burman screening design, followed by optimization using a central composite optimization design and validation of the optimized method as per ICHQ2(R2).
RESULTS: A novel HPTLC utilized pre-coated aluminum-backed HPTLC plates of Silica gel G 60 F254 using 10 µL/band injection volume, and the plate was developed using an isocratic mobile phase consisting of ethyl acetate: methanol: water (8.4:0.8:0.8v/v/v) in a twin trough chamber pre-saturated for 30 mins with vapors of 10 mL of mobile phase. The separated components were detected at a wavelength of 273 nm. The developed HPTLC method resulted in a retardation factor of 0.31 ± 0.02 for alpha arbutin and 0.42 ± 0.02 for niacinamide, respectively. Validation results revealed the HPTLC method's specificity (peak purity ≥ 0.999), linearity (over a studied concentration range of 200-800 ng/band for alpha arbutin and 400-1600 ng/band for niacinamide), sensitivity, accuracy, precision, and robustness.
CONCLUSION: The developed robust HPTLC method was successfully implemented for the sustainable testing of the alpha arbutin and niacinamide in the nanocosmeceutical formulations.