Quantifying alpha arbutin and niacinamide from nanocosmeceutical formulation matrix: AQbD driven high-performance thin-layer chromatographic method.

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.