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

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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Publication Details

Journal
Separations
Published
2026-03-14
DOI
https://doi.org/10.3390/separations13030094
Primary Topic
Analytical Methods in Pharmaceuticals
Type
article
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article

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

Khadejah D. Otaif
Separations
Analytical Methods in Pharmaceuticals
article

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

Khadejah D. Otaif
article en

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.

SeparationsVol. 13(3)
Jazan University (SA)
Openalex Percentile: Top 19%
Analytical Methods in Pharmaceuticals
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