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March 18, 2026Separations0 citationsOpen Access

HPLC-DAD Determination of Hydroquinone, Salicylic Acid, and Niacinamide in Skin-Whitening Products: Method Validation and Safety Evaluation

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KOKhadejah D. Otaif

Key Points

  • The main goal is to develop a reliable method to determine harmful ingredients in skin-whitening products.
  • Developed and validated an HPLC-DAD method for chemical analysis
  • Analyses followed ICH Q2(R1) guidelines
  • Assessment of 51 commercial and homemade skin-whitening products
  • Discrepancies between declared and actual ingredient concentrations were investigated
  • Risk assessment of systemic exposure to harmful ingredients performed.
  • Hydroquinone was found in 18.60% of commercial samples despite being prohibited.
  • None of the salicylic acid-containing products matched their labels.
  • Niacinamide appeared in 25.58% of the samples with non-compliance issues.
  • 62.50% of homemade products had undeclared hydroquinone.
  • Risk assessment indicated unacceptable exposure risks for several formulations.

Abstract

Skin-whitening products (SWPs) are widely used, yet many contain prohibited or misdeclared depigmenting agents posing safety concerns. This study developed and validated a sensitive and reliable HPLC-DAD method for the simultaneous determination of hydroquinone (HQ), salicylic acid (SAL), and niacinamide (NIC) in commercial and homemade SWPs. Validation followed ICH Q2(R1), demonstrating good specificity, linearity (R2 > 0.9999), method precision (%RSD < 2%), and LOD/LOQ values of 0.2 and 0.7 µg/mL for all analytes. Recoveries of 97.48–99.83% for HQ, 99.37–101.26% for NIC, and 83.04–95.38% for SAL were also obtained. Analysis of 51 products revealed major discrepancies between declared and measured contents. HQ was detected in 18.60% of commercial samples despite its prohibition in OTC cosmetic formulations; none of the SAL-containing products matched their labels, and NIC appeared in 25.58% of samples, with only one sample compliant with its declared content. Homemade products showed undeclared HQ in 62.50% of samples, 25% of samples exceeded the 2% permitted SAL limit, and unregulated multi-ingredient combinations. Risk assessment showed all HQ-containing commercial products and several homemade formulations posed unacceptable systemic exposure risks (MoS < 100). Overall, the proposed method provides a practical and accessible approach for routine quality control and market surveillance of cosmetic products.

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Cite This Study

Khadejah D. Otaif (2026) studied this question.

synapsesocial.com/papers/69ba43a84e9516ffd37a5150https://doi.org/10.3390/separations13030094
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