Method Equivalence Testing for Sunscreen Actives Using the ACQUITY UPLC H-Class PLUS System and ACQUITY UPLC H-Class System

Applications | 2018 | WatersInstrumentation
HPLC
Industries
Other
Manufacturer
Waters

Significance of the Topic


Analysis of chemical sunscreen agents is critical due to the established link between UV exposure and the development of skin cancer. Reliable analytical methods enable accurate quantitation of multiple UV filters in cosmetic formulations, supporting regulatory compliance, consumer safety, and effective quality control.

Objectives and Study Overview


This brief evaluates the performance equivalence between the ACQUITY UPLC H-Class PLUS System and the ACQUITY UPLC H-Class System for the separation, detection, and quantitation of six common sunscreen actives. Key system suitability parameters are compared across two column chemistries to confirm method transferability without revalidation.

Methodology and Instrumentation


  • Preparation of standards: six UV filters at 25 μg/mL in 60:40 water:methanol
  • Chromatographic columns: ACQUITY UPLC BEH C8 (1.7 μm, 2.1×50 mm) and ACQUITY UPLC HSS PFP (1.8 μm, 2.1×50 mm)
  • Mobile phase: A – water with 0.1% formic acid; B – methanol with 0.1% formic acid; gradient from 40% to 95% B over 4.5 min, 2.5 min hold, return to 40% B
  • Flow rate: 0.5 mL/min; injection volume: 5 μL; detection via UV and mass spectrometry
  • Data acquisition and processing with Empower 3 CDS; five replicate injections for retention time and peak area measurement


Key Results and Discussion


Overlaid chromatograms on both systems and both column types exhibited nearly identical separation profiles. Retention time reproducibility (RSD) was below 0.2% on the H-Class System and below 0.04% on the H-Class PLUS System. Comparable peak areas and retention times confirm that methods validated on the H-Class platform can be directly transferred to the H-Class PLUS platform without revalidation.

Benefits and Practical Applications


  • High precision and reproducibility support robust QC monitoring in sunscreen manufacturing
  • Seamless method transfer reduces downtime and validation costs when upgrading instrumentation
  • Efficient separations shorten analysis time and lower solvent usage


Future Trends and Potential Applications


Integration of advanced mass spectrometry workflows can enhance sensitivity and selectivity for trace impurities. Development of green chromatography methods and automation will further improve throughput and sustainability. Expanding this approach to other cosmetic ingredients and environmental matrices can broaden regulatory monitoring capabilities.

Conclusion


The ACQUITY UPLC H-Class PLUS System delivers equivalent or improved performance compared to the H-Class System for quantitative analysis of sunscreen actives. Its high reproducibility and straightforward method transfer facilitate efficient quality control and regulatory compliance in cosmetic analysis.

References


  1. Guy GP, Thomas CC, Thompson T, Watson M, Massetti GM, Richardson LC. Vital signs: Melanoma incidence and mortality trends and projections–United States, 1982–2030. MMWR Morb Mortal Wkly Rep. 2015;64(21):591–596.
  2. Guy GP, Machlin S, Ekwueme DU, Yabroff KR. Prevalence and costs of skin cancer treatment in the US, 2002–2006 and 2007–2011. Am J Prev Med. 2015;48:183–187.
  3. Stern RS. Prevalence of a history of skin cancer in 2007: results of an incidence-based model. Arch Dermatol. 2010;146(3):279–282.
  4. Robinson JK. Sun exposure, sun protection, and vitamin D. JAMA. 2005;294:1541–1543.
  5. World Health Organization. Solar ultraviolet radiation: Global burden of disease from solar ultraviolet radiation. Environ Burd Dis Ser. 2006;13.
  6. Islami F et al. Proportion and number of cancer cases and deaths attributable to potentially modifiable risk factors in the United States. CA Cancer J Clin. 2017. doi:10.3322/caac.21440.
  7. He QS, Xu N, Liao SF. Determination of 12 Sunscreen Agents in Cosmetics by High Performance Liquid Chromatography. Chin J Chromatogr. 2011;29:762–767.
  8. Pirotta G. Household and Personal Care Today. 2015;10(4):19–24.
  9. Salvador A, Chisvert A. Sunscreen analysis: a critical survey on UV filters determination. Anal Chim Acta. 2005;537(1):1–14.

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