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Validation of a Method for the Measurement of Caffeine in Water by HPLC-UV
Chemistry Department, National Measurement and Calibration Center (NMCC), Saudi Standards, Metrology and Quality Organization (SASO), Riyadh, Kingdom of Saudi Arabia
Chemistry Department, National Measurement and Calibration Center (NMCC), Saudi Standards, Metrology and Quality Organization (SASO), Riyadh, Kingdom of Saudi Arabia
Chemistry Department, National Measurement and Calibration Center (NMCC), Saudi Standards, Metrology and Quality Organization (SASO), Riyadh, Kingdom of Saudi Arabia
Chemistry Department, National Measurement and Calibration Center (NMCC), Saudi Standards, Metrology and Quality Organization (SASO), Riyadh, Kingdom of Saudi Arabia
Chemistry Department, National Measurement and Calibration Center (NMCC), Saudi Standards, Metrology and Quality Organization (SASO), Riyadh, Kingdom of Saudi Arabia
Chemistry Department, National Measurement and Calibration Center (NMCC), Saudi Standards, Metrology and Quality Organization (SASO), Riyadh, Kingdom of Saudi Arabia
- 1 Chemistry Department, National Measurement and Calibration Center (NMCC), Saudi Standards, Metrology and Quality Organization (SASO), Riyadh, Kingdom of Saudi Arabia
- 2 Chemistry Department, National Measurement and Calibration Center (NMCC), Saudi Standards, Metrology and Quality Organization (SASO), Riyadh, Kingdom of Saudi Arabia
- 3 Chemistry Department, National Measurement and Calibration Center (NMCC), Saudi Standards, Metrology and Quality Organization (SASO), Riyadh, Kingdom of Saudi Arabia
- 4 Chemistry Department, National Measurement and Calibration Center (NMCC), Saudi Standards, Metrology and Quality Organization (SASO), Riyadh, Kingdom of Saudi Arabia
- 5 Chemistry Department, National Measurement and Calibration Center (NMCC), Saudi Standards, Metrology and Quality Organization (SASO), Riyadh, Kingdom of Saudi Arabia
- 6 Chemistry Department, National Measurement and Calibration Center (NMCC), Saudi Standards, Metrology and Quality Organization (SASO), Riyadh, Kingdom of Saudi Arabia
Green and Sustainable Chemistry·Volume 13 (2023)·Pages 291–302·Published 6 November 2023·DOI10.4236/gsc.2023.134016
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Abstract
For the production of a reference material from caffeine solution, one of the methods of characterization was HPLC-UV since caffeine is very sensitive to the UV. In this work, a batch solution of caffeine in water reference material of 1000 mg/kg has been gravimetrically prepared using a calibrated analytical balance. A sample of this solution was diluted to 25 mg/kg for measurement by HPLC-UV in the range 10 - 50 mg/kg. The chromatographic separation was carried out by C-18 column and a mobile phase assembled of 75% water and 25% methanol ( v : v ). The detection was made by the UV detector at 275 nm. The validation of this analytical method was carried out in accordance with requirements of the EURACHEM and ICH guidelines. The selectivity, linearity, accuracy, precision and trueness (recovery and bias) of the method were studied. The validation results proved that the method is fit-for-purpose of measuring the caffeine concentration in water in the range 10 - 50 mg/kg using HPLC-UV.
KeywordsHPLC-UVCaffeineSelectivityLinearityPrecisionAccuracy
- Hilary, A.R. (2013) How Composition Methods Are Developed and Validated. Journal of Agriculture and Food Chemistry, 61, 8312-8316. https://pubmed.ncbi.nlm.nih.gov/23879867/ https://doi.org/10.1021/jf401033d
- IUPAC (2002) Harmonized Guidelines for Single-Laboratory Validation of Methods of Analysis. Pure and Applied Chemistry, 74, 835-855. https://publications.iupac.org/pac/74/5/0835/index.html https://doi.org/10.1351/pac200274050835
- Magnusson, B. and Omemark, U. (2014) Eurachem Guide: The Fitness for Purpose of Analytical Methods: A Laboratory Guide to Method Validation and Related Topics. https://www.eurachem.org/images/stories/Guides/pdf/MV_guide_2nd_ed_EN.pdf
- ISO (International Organization for Standardization). Standards Catalogue, 67: Food Technology. https://www.iso.org/ics/67/x/
- Breno, M.M., Victor, C., Allan, M.J., Mariana, M.F., Raquel, O.V. and Roberto, P. (2020) Validation of Analytical Methods in a Pharmaceutical Quality System: An Overview Focused on HPLC Methods. Química Nova, 43, 1190-1203. https://www.scielo.br/j/qn/a/RwZvtH6LYs5qtbGcVbFMc8c/?lang=en
- ISO/IEC 17025 (2017) General Requirements for the Competence of Testing and Calibration. https://www.iso.org/obp
- Aburuz, S., Millership, J. and McElnay, J. (2005) The Development and Validation of Liquid Chromatography Method for the Simultaneous Determination of Metformin and Glipizide, Gliclazide, Glibenclamide or Glimperide in Plasma. Journal of Chromatography B, 817, 277-286. https://europepmc.org/article/med/15686996 https://doi.org/10.1016/j.jchromb.2004.12.018
- Raposo, F. (2016) Evaluation of Analytical Calibration Based on Least Squares Linear Regression for Instrumental Techniques: A Tutorial Review. Trends in Analytical Chemistry, 77, 167-185. https://doi.org/10.1016/j.trac.2015.12.006
- ICH (2005) ICH Harmonised Tripartite Guideline, Validation of Analytical Procedures: Text and Methodology Q2 (R1). https://database.ich.org/sites/default/files/Q2%28R1%29%20Guideline.pdf
- U. S. Food and Drug Administration (2015) Analytical Procedures and Methods Validation for Drugs and Biologics. Guidance for Industry. https://www.fda.gov/files/drugs/published/Analytical-Procedures-and-Methods-Validation-for-Drugs-and-Biologics.pdf
- Shehata, A.B., AlAskar, A.R., AlRasheed, M.A., AlZahrany, A.M., AlKharraa, F.A. and AlSowailem, S.A. (2023) Development of a Certified Reference Material from Caffeine Solution for Assuring the Quality of Food and Drug Measurements. Green and Sustainable Chemistry, 13, 216-236. https://www.scirp.org/journal/gsc https://doi.org/10.4236/gsc.2023.133012