quantification of active ingredients in skin lightening creams using hplc method in iranian market

Background: skin-lightening creams, a category of cosmetic products, contain active whitening agents such as hydroquinone (hq), arbutin, and kojic acid (ka), along with ascorbic acid (aa), propyl paraben (pp), and butylated hydroxyanisole (bha). due to the potential adverse effects associated with excessive concentrations of these ingredients, it is essential to monitor their levels in skin-lightening products to ensure compliance with acceptable ranges. objectives: therefore, this study, as a cross-sectional study, aimed to identify and quantify the aforementioned compounds in 58 commercial skin-whitening creams. methods: following sample extraction and preparation, a high-performance liquid chromatography (hplc) method was developed for the simultaneous detection and quantification of hq, arbutin, ka, aa, pp, and bha in the samples. results: the six target analytes were successfully separated within 25 minutes using hplc, demonstrating strong linearity (r2 = 0.999) and satisfactory recoveries (95.29 - 105.35%), all achieved within the consistent run time. regulatory non-compliance was observed in some samples: (a) the hq exceeded the permissible limit [2% based on food and drug administration (fda)/world health organization (who) guidelines] in 2 samples (0.011% and 0.482%); (b) arbutin surpassed the 2% threshold based on the scientific committee on consumer safety (sccs) in 4 samples (0.479%, 0.631%, 0.887%, and 0.992%). however, ka, pp, and bha remained within safe limits in all tested products. these findings suggest that a subset of commercially available skin-lightening creams may pose toxicity risks due to inaccurate labeling. conclusions: although non-compliant samples were limited in this study, stricter regulatory monitoring and control of skin-lightening products are recommended to ensure adherence to safety standards for the specified ingredients.