Issue

Vol. 35 No. 2 (2023): Vol 35 Issue 2, 2023

Copyright (c) 2023 AJC

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.

Liquid Chromatographic-Electrospray Ionization-Mass Spectrometry Method for the Simultaneous Determination of Gramicidin, Neomycin & Triamcinolone Acetonide and Characterization of Novel Forced Degradation Products

https://doi.org/10.14233/ajchem.2023.26922
Pridhvi Krishna Gaddey
Department of Pharmaceutical Analysis, GITAM Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam-530045, India
Raja Sundararajan
Department of Pharmaceutical Analysis, GITAM Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam-530045, India

Corresponding Author(s) : Raja Sundararajan

sraja61@gmail.com

Asian Journal of Chemistry, Vol. 35 No. 2 (2023): Vol 35 Issue 2, 2023

Abstract

The dosage form iotrim (gramicidin, neomycin and triamcinolone) is a combination of two antibiotics (gramicidin and neomycin) and a steroid (triamcinolone). The antibiotics work by killing the bacteria that cause infections. The steroid blocks the action of chemical messengers (prostaglandins) that make the affected area red, swollen and itchy. Consequently, there was still a need to develop a simple, less time consuming and economical method for the simultaneous determination of gramicidin, neomycin and triamcinolone acetonide. The current work is an effort to develop a fast and reproducible LC-MS technique for the simultaneous estimation of gramicidin, neomycin and triamcinolone acetonide. The objective of the present procedure was to validate and develop a precise and accurate liquid chromatography-mass spectrometry (LC-MS) technique for the simultaneous quantification of gramicidin, neomycin and triamcinolone acetonide. Gramicidin, neomycin and triamcinolone acetonide were monitored on Shimadzu-8045 mass spectrometer equipped with electro spray ionization interface. The retention times of gramicidin, neomycin and triamcinolone acetonide were found at 9.145 min, 7.273 min and 2.435 min, respectively. The limit of detection (LOD) results for gramicidin, neomycin and triamcinolone acetonide were observed to be 0.15, 1.5 and 0.6 μg/mL, respectively while the limit of quantification (LOQ) results were observed to be 0.5, 5, 2 μg/mL concentration, respectively. The linear range for gramicidin, neomycin and triamcinolone acetonide were found in the concentration ranges from 1.25-7.5 μg/mL, 12.5-75 μg/mL and 5-30 μg/mL with regression coefficient of 0.9991, 0.9996, 0.9999, respectively. Accuracy values for gramicidin, neomycin and triamcinolone acetonide were found to be in the range of 98.64%, 99.4%, 99.5% respectively. The % RSD for six replicates in precision was less than 2%. According to ICH Q2(R1) recommendations, this method was successfully tested with LC-MS to confirm the chemical structures of newly produced degradation products of triamcinolone acetonide and neomycin. The developed process was validated efficaciously as per ICH guidelines.

Keywords

Gramicidin Neomycin Triamcinolone acetonide Electro spray ionization Limit of detection
Krishna Gaddey, P., & Sundararajan, R. (2023). Liquid Chromatographic-Electrospray Ionization-Mass Spectrometry Method for the Simultaneous Determination of Gramicidin, Neomycin & Triamcinolone Acetonide and Characterization of Novel Forced Degradation Products. Asian Journal of Chemistry, 35(2), 379–388. https://doi.org/10.14233/ajchem.2023.26922
Download Citation
Endnote/Zotero/Mendeley (RIS)
BibTeX
References
  1. Y.V. Karpievitch, A.D. Polpitiya, G.A. Anderson, R.D. Smith and A.R. Dabney, Ann. Appl. Stat., 4, 1797 (2010); https://doi.org/10.1214/10-AOAS341
  2. J.A. Orwa, C. Govaerts, E. Roets, A. Van Schepdael and J. Hoogmartens, Chromatographia, 53, 17 (2001); https://doi.org/10.1007/BF02492421
  3. C. Blanchard, L. Brooks, A. Beckley, J. Colquhoun, S. Dewhurst and P.M. Dunman, Antimicrob. Agents Chemother., 60, 862 (2016); https://doi.org/10.1128/AAC.02083-15
  4. T. Yilmaz, M. Cordero-Coma and T.J. Federici, Expert. Opin. Drug. Metab. Toxicol., 7, 1327 (2011); https://doi.org/10.1517/17425255.2011.606215
  5. E. Adams, R. Schepers, L.W. Gathu, R. Kibaya, E. Roets and J. Hoogmartens, J. Pharm. Biomed. Anal., 15, 505 (1997); https://doi.org/10.1016/S0731-7085(96)01881-X
  6. D.M. Salom, M.C. Bafi, L. Brace and C. Abad, Anal. Chim. Acta, 352, 309 (1997); https://doi.org/10.1016/S0003-2670(97)00260-2
  7. R. Bruce-Binns and T. Kiyoshi, J. Pharm. Sci., 73, 69 (1984).
  8. B. Balaswami, V.R. Peddakotla, S.R. Bandi and S. Pagidirai, Int. J. Pharm. Sci. Res., 9, 4187 (2018).
  9. Y.M. Permata, M. Bachri, J. Reveny and F.M. Sibuea, Open Access Maced. J. Med. Sci., 7, 3841 (2019); https://doi.org/10.3889/oamjms.2019.516
  10. M. Sathwik, P.V. Sai Raghav, A. Shanta Kumari, S.K. Abdul Rahaman, Indo. Glob. J. Pharm. Sci., 8, 88 (2018); https://doi.org/10.35652/IGJPS.2018.8891
  11. D. Xiang-dong, L. Hui-yi, Z. Qi-Ming, T. Song-Jiu and Z. Zheng-Xing, Chin. J. Pharm. Anal., 27, 212 (2007).
  12. R. Oertel, U. Renner and W. Kirch, J. Pharm. Biomed. Anal., 35, 633 (2004); https://doi.org/10.1016/j.jpba.2004.01.018
  13. D.G. Mascher, C.P. Unger and H.J. Mascher, J. Pharm. Biomed. Anal., 43, 691 (2007); https://doi.org/10.1016/j.jpba.2006.08.008
  14. M. Zu, J. Jiang, H. Zhao, S. Zhang, Y. Yan, S. Qiu, S. Yuan, J. Han, Y. Zhang, W. Guo and S. Yang, J. Chromatogr. B, 1093, 52 (2018); https://doi.org/10.1016/j.jchromb.2018.06.055
  15. K. Stypulkowska, A. Blazewicz, Z. Fijalek, M. Warowna-Grzeskiewicz and K. Srebrzynska, J. Pharm. Biomed. Anal., 76, 207 (2013); https://doi.org/10.1016/j.jpba.2012.12.025
  16. H. Hamidia, M. Zarrineha, A. Es-haghi and A. Ghasempoura, J. Chromatogr. A, 1625, 461343 (2020); https://doi.org/10.1016/j.chroma.2020.461343
  17. V.P. Hanko and J.S. Rohrer, J. Pharm. Biomed. Anal., 43, 131 (2007); https://doi.org/10.1016/j.jpba.2006.06.024
  18. A.L. Huidobro, A. García and C. Barbas, J. Pharm. Biomed. Anal., 49, 1303 (2009); https://doi.org/10.1016/j.jpba.2009.03.005
  19. A.J.P. van Heugten, W. de Boer, W.S. de Vries, C.M.A. Markesteijn and H. Vromans, J. Pharm. Biomed. Anal., 149, 265 (2018); https://doi.org/10.1016/j.jpba.2017.11.026
  20. M. de L.T. Vieira, R.P. Singh and H. Derendorf, J. Chromatogr. B, 878, 2967 (2010); https://doi.org/10.1016/j.jchromb.2010.08.048
  21. S. Sudsakorn, L. Kaplan and D.A. Williams, J. Pharm. Biomed. Anal., 40, 1273 (2006); https://doi.org/10.1016/j.jpba.2005.09.018
  22. S.A. Doppenschmitt, B. Scheldel, F. Harrison and J.P. Surmann, J. Chromatogr. B, 682, 79 (1996); https://doi.org/10.1016/0378-4347(96)00060-6
  23. I.C. César, R.M.D. Byrro, F.F. de Santana e Silva Cardoso, I.M. Mundim, L. de Souza Teixeira, W.C. de Sousa, S.A. Gomes, K.B. Bellorio, J.M. Brêtas and G.M. Pianetti, J. Mass Spectrom., 46, 320 (2011); https://doi.org/10.1002/jms.1896
  24. W. Sun, S. Ho, X.R. Fang, T.O. Shea and H. Liu, J. Pharm. Biomed. Anal., 153, 267 (2018); https://doi.org/10.1016/j.jpba.2018.02.052
  25. H. Liu, M. Yang, P. Wu, J. Guan, L. Men, H. Lin, X. Tang, Y. Zhao and Z. Yu, J. Pharm. Biomed. Anal., 104, 105 (2015); https://doi.org/10.1016/j.jpba.2014.11.028
  26. S.Q. Zhang, J. Chromatogr. B, 879, 548 (2011); https://doi.org/10.1016/j.jchromb.2011.01.012
Read More
Author biographies is not available.
Download
PDF
Statistic
Read Counter : 1 Download : 0