Chromatographic Methods for the Determination of Aminexil, Pyridoxine, and Niacinamide in a Novel Cosmetic Hair Preparation.

Background: Aminexil, a new compound patented by L'Oreal, has a stimulating effect on human keratin fibers. Pyridoxine HCl and niacinamide are added to boost the hair tonic effect of aminexil.

Objective: Two novel chromatographic methods were developed for the determination of aminexil (AX), niacinamide (NA) and pyridoxine HCl (PD) in the novel hair tonic preparation.

Methods: The developed methods were high-performance liquid chromatography (HPLC) and thin layer chromatography (TLC) with densitometric determination. Different experimental parameters were investigated and optimized to achieve complete baseline separation and well resolved peaks. The RP-HPLC separation was achieved using a Thermoscientific BDS hypersil C18 (250 × 4.6 mm, 5 µm) column using 0.005 M hexane sulfonic acid: methanol (80: 20, v/v) as a mobile phase. For the TLC method, the three analytes were partitioned between propanol: toluene: ammonia solution (40:60:2, v/v/v) and fluorescent silica plates. The two methods were validated in compliance with International Conference on Harmonization (ICH) guidelines. The obtained data were statistically analyzed to confirm the existing results. The developed methods were successfully applied for determination of the studied drugs in pure forms and in the cosmetic preparation.

Results: For the HPLC method, the RSDs of AX, NA and PD were 0.70, 0.88 and 1.17 respectively. For the TLC method, the RSDs of AX, NA and PD were 1.06, 1.37 and 0.73 respectively.

Conclusions: The proposed chromatographic methods showed high sensitivity and selectivity for the three compounds under analysis in the laboratory prepared mixture and in the hair tonic preparation.

Highlights: Aminexil, Pyridoxine, Niacinamide, HPLC. The present work offers two reproducible, accurate, validated, time and cost saving alternatives for the quantitative and qualitative determination of medicated hair preparation.