Validation of an HPLC method for the determination of some β-lactams antibiotics using a green analytical technique
Keywords:
Ethanol, Green analytical chemistry, HPLC-PDA, β-lactams antibiotics
Abstract
Green analytical chemistry (GAC) primary goal is to develop environmental and health-friendly analytical methods by reduction or replacement of hazardous substances from analytical procedures. In this research, the application of GAC to quantify five β-lactams antibiotics (cefuroxime sodium, cefaclor, ertapenem sodium, ampicillin sodium and sulbactam sodium) by high-performance liquid chromatography (HPLC) using photodiode arrays (PDA) detector was developed. To achieve this, ethanol was used as a green replacement for methanol and acetonitrile, common solvents in chromatographic procedures. Several chromatographic conditions were investigated to accomplish the optimal conditions. The method validation followed the ICH Q2 (R1) guideline, and the developed method was successfully applied for quantifying some pharmaceutical products.
References
Barbour A, S. S., Rout WR, Ben-David K, Burkhardt O, Derendorf H. (2009). Soft tissue penetration of cefuroxime determined by clinical microdialysis in morbidly obese patients undergoing abdominal surgery. International Journal of Antimicrobial Agents, 34(3), 231–235. doi: https://doi.org/10.1016/j.ijantimicag.2009.03.019
Briscoe, S. E., McWhinney, B. C., Lipman, J., Roberts, J. A., & Ungerer, J. P. (2012). A method for determining the free (unbound) concentration of ten beta-lactam antibiotics in human plasma using high performance liquid chromatography with ultraviolet detection. Journal of Chromatography B, 907, 178-184. doi: https://doi.org/10.1016/j.jchromb.2012.09.016
de la Guardia, M., & Garrigues, S. (2020). Past, present and future of green analytical chemistry.
Dong, M. (2019). HPLC/UHPLC Instrumentation and Trends HPLC and UHPLC for Practicing Scientists (pp. 81-115).
Fiocchi A, C. E., Beghi G, Terracciano L. . (2010). Paediatric upper respiratory infections: the role of antibiotics. International Journal of Immunopathology and Pharmacology, 23(1), 56–60. doi: https://doi.org/10.1177/03946320100230S115
G M Salzmann, F. D. N., F von Knoch, J Tuebel, R Gradinger, A B Imhoff, et al. (2007). Effects of cefuroxime on human osteoblasts in vitro. Journal of Biomedical Materials Research A, 82(2), 462–468. doi: https://doi.org/10.1002/jbm.a.31158
Gałuszka, A., Migaszewski, Z., & Namieśnik, J. (2013). The 12 principles of green analytical chemistry and the SIGNIFICANCE mnemonic of green analytical practices. TrAC Trends in Analytical Chemistry, 50, 78-84.
Ghosh, P., Cao, X., Pal, J., Chowdhury, S., Saha, S., Nandi, S., & Roy, P. (2018). Mathematical Modeling for the Prevention of Methanol Poisoning Through Ethanol by Impulsive Way. Differential Equations and Dynamical Systems, 29. doi: 10.1007/s12591-018-0420-z
International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use. (2005). ICH Topic Q 2 (R1) Validation of Analytical Procedures: Text and Methodology. Switzerland.
International conference on harmonization of technical requirements for registration of pharmaceuticals for human use. (2021). Impurities: guideline for residual solvents Q3C (R8). Switzerland.
Joint Formulary Committee. (2022). British National Formulary (pp. 1853). UK: BMJ Group, Pharmaceutical Press.
Joshi, D. R., & Adhikari, N. (2019). An overview on common organic solvents and their toxicity. J. Pharm. Res. Int, 28(3), 1-18.
Lidia Moreira Lima, B. N., Monteiro da Silva, Gisele Barbosa, Eliezer J. Barreiro. (2020). β -Lactam antibiotics: an overview from a medicinal chemistry perspective. European Journal of Medicinal Chemistry, 208, 112829. doi: https://doi.org/10.1016/j.ejmech.2020.112829
Seung-Hyun Jeong, J.-H. J., Hea-Young Cho, Yong-Bok Lee (2021). Population Pharmacokinetic Analysis of Cefaclor in Healthy Korean Subjects. Pharmaceutics, 13(5), 754. doi: https://doi.org/10.3390/pharmaceutics13050754
United States Pharmacopeia Convention. (2020). USP 43-NF 38.
Vazquez JC, A. E. (2011). Treatments for symptomatic urinary tract infections during pregnancy. Cochrane Database of Systematic Reviews, 1. doi: https://doi.org/10.1002/14651858.CD002256.pub2
Wang, Z., Richter, S. M., Rozema, M. J., Schellinger, A., Smith, K., & Napolitano, J. G. (2017). Potential Safety Hazards Associated with Using Acetonitrile and a Strong Aqueous Base. Organic Process Research & Development, 21(10), 1501-1508. doi: 10.1021/acs.oprd.7b00158
Yabré, M., Ferey, L., Somé, I. T., & Gaudin, K. (2018). Greening reversed-phase liquid chromatography methods using alternative solvents for pharmaceutical analysis. Molecules, 23(5), 1065. doi: https://doi.org/10.3390/molecules23051065
Briscoe, S. E., McWhinney, B. C., Lipman, J., Roberts, J. A., & Ungerer, J. P. (2012). A method for determining the free (unbound) concentration of ten beta-lactam antibiotics in human plasma using high performance liquid chromatography with ultraviolet detection. Journal of Chromatography B, 907, 178-184. doi: https://doi.org/10.1016/j.jchromb.2012.09.016
de la Guardia, M., & Garrigues, S. (2020). Past, present and future of green analytical chemistry.
Dong, M. (2019). HPLC/UHPLC Instrumentation and Trends HPLC and UHPLC for Practicing Scientists (pp. 81-115).
Fiocchi A, C. E., Beghi G, Terracciano L. . (2010). Paediatric upper respiratory infections: the role of antibiotics. International Journal of Immunopathology and Pharmacology, 23(1), 56–60. doi: https://doi.org/10.1177/03946320100230S115
G M Salzmann, F. D. N., F von Knoch, J Tuebel, R Gradinger, A B Imhoff, et al. (2007). Effects of cefuroxime on human osteoblasts in vitro. Journal of Biomedical Materials Research A, 82(2), 462–468. doi: https://doi.org/10.1002/jbm.a.31158
Gałuszka, A., Migaszewski, Z., & Namieśnik, J. (2013). The 12 principles of green analytical chemistry and the SIGNIFICANCE mnemonic of green analytical practices. TrAC Trends in Analytical Chemistry, 50, 78-84.
Ghosh, P., Cao, X., Pal, J., Chowdhury, S., Saha, S., Nandi, S., & Roy, P. (2018). Mathematical Modeling for the Prevention of Methanol Poisoning Through Ethanol by Impulsive Way. Differential Equations and Dynamical Systems, 29. doi: 10.1007/s12591-018-0420-z
International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use. (2005). ICH Topic Q 2 (R1) Validation of Analytical Procedures: Text and Methodology. Switzerland.
International conference on harmonization of technical requirements for registration of pharmaceuticals for human use. (2021). Impurities: guideline for residual solvents Q3C (R8). Switzerland.
Joint Formulary Committee. (2022). British National Formulary (pp. 1853). UK: BMJ Group, Pharmaceutical Press.
Joshi, D. R., & Adhikari, N. (2019). An overview on common organic solvents and their toxicity. J. Pharm. Res. Int, 28(3), 1-18.
Lidia Moreira Lima, B. N., Monteiro da Silva, Gisele Barbosa, Eliezer J. Barreiro. (2020). β -Lactam antibiotics: an overview from a medicinal chemistry perspective. European Journal of Medicinal Chemistry, 208, 112829. doi: https://doi.org/10.1016/j.ejmech.2020.112829
Seung-Hyun Jeong, J.-H. J., Hea-Young Cho, Yong-Bok Lee (2021). Population Pharmacokinetic Analysis of Cefaclor in Healthy Korean Subjects. Pharmaceutics, 13(5), 754. doi: https://doi.org/10.3390/pharmaceutics13050754
United States Pharmacopeia Convention. (2020). USP 43-NF 38.
Vazquez JC, A. E. (2011). Treatments for symptomatic urinary tract infections during pregnancy. Cochrane Database of Systematic Reviews, 1. doi: https://doi.org/10.1002/14651858.CD002256.pub2
Wang, Z., Richter, S. M., Rozema, M. J., Schellinger, A., Smith, K., & Napolitano, J. G. (2017). Potential Safety Hazards Associated with Using Acetonitrile and a Strong Aqueous Base. Organic Process Research & Development, 21(10), 1501-1508. doi: 10.1021/acs.oprd.7b00158
Yabré, M., Ferey, L., Somé, I. T., & Gaudin, K. (2018). Greening reversed-phase liquid chromatography methods using alternative solvents for pharmaceutical analysis. Molecules, 23(5), 1065. doi: https://doi.org/10.3390/molecules23051065
Published
2024-06-25
How to Cite
Truong Quoc, K. (2024). Validation of an HPLC method for the determination of some β-lactams antibiotics using a green analytical technique. Indonesian Journal of Pharmacy. https://doi.org/10.22146/ijp.8161
Issue
Section
Research Article
