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Green Simultaneous Chromatographic Separation of Pyridostigmine Bromide and Its Related Substances in Pure Form, Tablets and Spiked Human Plasma.
J Chromatogr Sci 2019; 57(7):653-661JC

Abstract

A green, accurate and specific high-performance thin-layer chromatographic (HPTLC) method was developed and validated for simultaneous quantitative determination of pyridostigmine bromide (PR), impurity B (IMP B);3-hydroxy-N-methylpyridinium bromide and impurity A (IMP A); pyridin-3-yl-dimethylcarbamate. The two pharmacopeial impurities are also its main inactive metabolites. Furthermore, IMP B is known to be its alkaline-induced degradation product. Achievable separation of the studied components required silica gel HPTLC F254 plates as a stationary phase and acetone: acetic acid (80:20, v/v) as a developing system. Scanning of the separated bands was done at 260 nm. According to green solvent selection guidelines, acetone and acetic acid are eco-friendly solvents. Validation of the developed method was insured by its acquiesce to international conference on harmonization (ICH) guidelines. The introduced method was successfully achieved for the quantitative determination of PR, IMP B and IMP A in the range of 0.4-10, 2-11 and 0.4-3.5 μg/band, respectively. Successful application of the developed method was done for determination of PR in human plasma in the range of 0.6-10 μg/band, so the proposed HPTLC can be applied in the pharmacokinetic studies. The studied drug was also analyzed in Mestinon® tablets using the developed method.

Authors+Show Affiliations

Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Beni-Suef University, Alshaheed Shehata Ahmad Hegazy St., Beni-Suef, Egypt. Department of Pharmaceutical Chemistry, College of Pharmacy, Taif University, Al-Hawiah, Taif, Saudi Arabia.Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Beni-Suef University, Alshaheed Shehata Ahmad Hegazy St., Beni-Suef, Egypt.Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Beni-Suef University, Alshaheed Shehata Ahmad Hegazy St., Beni-Suef, Egypt.Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Beni-Suef University, Alshaheed Shehata Ahmad Hegazy St., Beni-Suef, Egypt.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31204433

Citation

Naguib, Ibrahim A., et al. "Green Simultaneous Chromatographic Separation of Pyridostigmine Bromide and Its Related Substances in Pure Form, Tablets and Spiked Human Plasma." Journal of Chromatographic Science, vol. 57, no. 7, 2019, pp. 653-661.
Naguib IA, Abdelaleem EA, Emam AA, et al. Green Simultaneous Chromatographic Separation of Pyridostigmine Bromide and Its Related Substances in Pure Form, Tablets and Spiked Human Plasma. J Chromatogr Sci. 2019;57(7):653-661.
Naguib, I. A., Abdelaleem, E. A., Emam, A. A., & Abdallah, F. F. (2019). Green Simultaneous Chromatographic Separation of Pyridostigmine Bromide and Its Related Substances in Pure Form, Tablets and Spiked Human Plasma. Journal of Chromatographic Science, 57(7), pp. 653-661. doi:10.1093/chromsci/bmz043.
Naguib IA, et al. Green Simultaneous Chromatographic Separation of Pyridostigmine Bromide and Its Related Substances in Pure Form, Tablets and Spiked Human Plasma. J Chromatogr Sci. 2019 Aug 1;57(7):653-661. PubMed PMID: 31204433.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Green Simultaneous Chromatographic Separation of Pyridostigmine Bromide and Its Related Substances in Pure Form, Tablets and Spiked Human Plasma. AU - Naguib,Ibrahim A, AU - Abdelaleem,Eglal A, AU - Emam,Aml A, AU - Abdallah,Fatma F, PY - 2018/02/21/received PY - 2019/01/04/revised PY - 2019/04/29/accepted PY - 2019/6/18/pubmed PY - 2019/9/3/medline PY - 2019/6/18/entrez SP - 653 EP - 661 JF - Journal of chromatographic science JO - J Chromatogr Sci VL - 57 IS - 7 N2 - A green, accurate and specific high-performance thin-layer chromatographic (HPTLC) method was developed and validated for simultaneous quantitative determination of pyridostigmine bromide (PR), impurity B (IMP B);3-hydroxy-N-methylpyridinium bromide and impurity A (IMP A); pyridin-3-yl-dimethylcarbamate. The two pharmacopeial impurities are also its main inactive metabolites. Furthermore, IMP B is known to be its alkaline-induced degradation product. Achievable separation of the studied components required silica gel HPTLC F254 plates as a stationary phase and acetone: acetic acid (80:20, v/v) as a developing system. Scanning of the separated bands was done at 260 nm. According to green solvent selection guidelines, acetone and acetic acid are eco-friendly solvents. Validation of the developed method was insured by its acquiesce to international conference on harmonization (ICH) guidelines. The introduced method was successfully achieved for the quantitative determination of PR, IMP B and IMP A in the range of 0.4-10, 2-11 and 0.4-3.5 μg/band, respectively. Successful application of the developed method was done for determination of PR in human plasma in the range of 0.6-10 μg/band, so the proposed HPTLC can be applied in the pharmacokinetic studies. The studied drug was also analyzed in Mestinon® tablets using the developed method. SN - 1945-239X UR - https://www.unboundmedicine.com/medline/citation/31204433/Green_Simultaneous_Chromatographic_Separation_of_Pyridostigmine_Bromide_and_Its_Related_Substances_in_Pure_Form_Tablets_and_Spiked_Human_Plasma_ L2 - https://academic.oup.com/chromsci/article-lookup/doi/10.1093/chromsci/bmz043 DB - PRIME DP - Unbound Medicine ER -