Ganesh Gajeli, Smita Kumbhar, Gazala Patel, Shivprasad Patil
Ganesh Gajeli, Smita Kumbhar, Gazala Patel, Shivprasad Patil*
Department of Pharmaceutical Quality Assurance, D.S.T.S Mandal’s College of Pharmacy, Solapur 413004, Maharashtra, India.
Volume - 12,
Issue - 2,
Year - 2022
A novel UV-Spectroscopy method was developed and validated for the estimation of L-glutathione in bulk and dosage form with congo red. The wavelength at which L-glutathione and congo red mixture product showed maximum absorption at 568nm in distilled water. The developed method range was found to be10-90µg/ml. The developed method validated for linearity, precision, range, limit of detection, the limit of quantification, robustness, specificity, system suitability. The regression equation was found to be y = 0.0045x + 0.121 with correlation coefficient R² = 0.9983. The limit of detection and the quantification limit was 5.05 µg/ml and 15.32 µg/ml respectively. The developed method was found to be linear, precise, robust, economical for the evaluation of L-glutathione in bulk and dosage form.
Cite this article:
Ganesh Gajeli, Smita Kumbhar, Gazala Patel, Shivprasad Patil. Development and Validation of Novel UV Spectroscopy Method for the Estimation of L-Glutathione in Bulk and Formulation with Congo Red. Asian Journal of Pharmaceutical Analysis. 2022; 12(2):78-2. doi: 10.52711/2231-5675.2022.00014
Ganesh Gajeli, Smita Kumbhar, Gazala Patel, Shivprasad Patil. Development and Validation of Novel UV Spectroscopy Method for the Estimation of L-Glutathione in Bulk and Formulation with Congo Red. Asian Journal of Pharmaceutical Analysis. 2022; 12(2):78-2. doi: 10.52711/2231-5675.2022.00014 Available on: https://ajpaonline.com/AbstractView.aspx?PID=2022-12-2-2
1. British Pharmacopoeia, vol. 1, Her Majesty’s Stationary Office, London, United Kingdom, 2005, pp. 924–926.
2. L-glutathione [internet]. Drug Bank [cited Oct 24, 2021]. Available from: https://go.drugbank.com/drugs/DB00143.
3. L-glutathione image [internet]. wikipidia [cited Oct 24 2021]. Available from: https://en.wikipedia.org/wiki/File:Glutathione-skeletal.svg
4. A.P. Senft, T.P. Dalton, H.G. Shertzer, Determining glutathione and glutathione disulfide using the fluorescence probe o-phthalaldehyde, Anal. Biochem. 280 (2000) 80–86.
5. H. Wang, W.S. Wang, H.S. Zhang, A Spectrofluorimetric method for cysteine and glutathione using the fluorescence system of Zn(II)-8-hydroxyquinoline-5-sulfonic acid complex, Spectrochim. Acta A 57A (2001) 2403–2407.
6. S.C. Liang, H. Wang, Z.M. Zhang, X. Zhang, H.S. Zhang, Direct spectrofluorimetric determination of glutathione in biological samples using 5-maleimidyl-2-(m- methyl phenyl) benzoxazole, Anal. Chim. Acta 451 (2002) 211–219.
7. ICH Q2(R1). Validation of Analytical Procedures: Text and Methodology. ICH Harmonised Tripartite Guidelines, 1994.
8. British Pharmacopoeia, vol. 1, Her Majety’s Stationary Office, London, United Kingdom, 2005, pp. 924–926.
9. D.W. Lamson, M.S. Brignall, The use of nebulized glutathione in the treatment of emphysema: a case report, Altern. Med. Rev. 5 (2000) 429–431.
10. Zainab A. Bagalkote, Ganesh Gajeli. UV Spectrophotometric Method Development and Validation of Carbimazole in Bulk and Tablet Dosage form. Asian Journal of Pharmaceutical Research. 2021; 11(3):163-166.
11. Suryawanshi Anuja, Ansari Afaque, Kalshetti Mallinath. UV Spectrophotometric Method Development and Validation of Luliconazole in Bulk and Formulation. Research Journal of Pharmacy and Technology; Raipur Vol. 14, Iss. 7, (Jul 2021): 3826-3828.
12. PA Jadhav, CS Raut, JP Bidada, BB Buwa, PN Dhabale, SC Dhawale. Development and Statistical Validation of UV Spectrophotometric Method for Estimation of Griseofulvin in Tablet Dosage Form. Asian J. Research Chem. 3(2): April- June 2010; Page 404-406.
13. K. Vijaya Sri, S. Sravani, M. Shiva Kumar. Development and Validation of UV Spectrophotometric Method for Estimation of Lurasidone in Bulk and Pharmaceutical Formulations. Asian J. Pharm. Res. 5(2): April-June 2015; Page 102-107.
14. DVS Roopa Sirisha Doppa, Sathish Kumar Konidala, Sheik Khanabhi. Development and Validation of UV Spectroscopic Method for the Determination of Ranolazine in Bulk and Formulation. Research J. Pharm. and Tech. 2019; 12(10):5007-5010.
15. A.J.C. Hartfield, C. Bachelor-McAuley, R.C. Compton, Electrochemical determina- tion of glutathione: a review, Analyst 137 (2012) 2285–2296.
16. Vaishnavi Dulange and G.B. Gajeli Development and Validation of UV Spectroscopy Method for the Estimation of Dolutegravir in Bulk and Pharmaceutical Dosage Form. Asian Journal of Pharmaceutical Analysis,2021; 11(3): July-sep.
17. E. Bolonska-Sikora, J. Ozczuldlowski, Z. Witkiewicz, D. Widel, Glutathione: method of sample preparation for chromatography and capillary electrophoresis, Chemik 66 (2012) 929–942.
18. P. Monostori, G. Wittmann, E. Karg, S. Turi, Determination of glutathione and glu- tathione disulfide in biological samples: an in-depth review, J. Chromatogr. B 877 (2009) 3331–3346.
19. L. Manna, L. Valvo, P. Betto, Determination of oxidized and reduced glutathione in pharmaceuticals by reversed-phase high-performance liquid chromatography with dual electrochemical detection, J. Chromatogr. A 846 (1999) 59–64.
20. C.S. Yang, S.C. Chang, P.J. Tsai, W.Y. Chen, J.S. Kuo, Simultaneous measurement of ascorbic acid and glutathione: application of microdialysis and online HPLC with Au/Hg electrode in anaesthetized rat liver, J. Liq. Chromatogr. Relat. Technol. 21 (1998) 3139–3148.
21. Sushil D. Patil, Sayali K. Chaure, Sanjay Kshirsagar. Development and validation of UV spectrophotometric method for Simultaneous estimation of Empagliflozin and Metformin hydrochloride in bulk drugs. Asian J. Pharm. Ana. 2017; 7(2): 117-123.
22. X.M. Guan, B. Hoffman, C. Dwivedi, D.P. Matthees, A simultaneous liquid chromatography/mass spectrometric assay of glutathione, cysteine, homocysteine and their disulfides in biological samples, J. Pharm. Biomed. Anal. 31 (2003) 251–261.
23. A.F. Loughlin, G.L. Skiles, D.W. Alberts, W.H. Schaefer, An ion exchange liquid chromatography-mass spectrometry method for the determination of reduced and oxi- dized glutathione and glutathione conjugates in hepatocytes, J. Pharm. Biomed. Anal. 26 (2001) 131–142.
24. Jyoti Mittha, Bhavana Habib. UV Spectrophotometric Method Development and Validation of Dasatinib in Bulk and Formulation. Asian Journal of Pharmaceutical Analysis. 2021; 11(3):203-206.
25. Y. Ma, F. Xiang, W. Jin, L. Yu, Determination of total glutathione in yeasts by high- performance liquid chromatography with dansylation, Z. Naturforsch. C 65 (2010) 391–394.
26. R. Kand’a´r, P. Za´kova´, H. Lotkova´, O. Kucera, Z. Cervinkova´, Determination of reduced and oxidized glutathione in biological samples using liquid chromatography with fluorimetric detection, J. Pharm. Biomed. Anal. 43 (2007) 1382–1387.
27. S.I. Yakubu, I.A. Yakasai, A. Musa, Spectrofluorimetric assay method for glutathione and glutathione transferase using monobromobimane, J. Basic Clin. Pharmcol. 2 (2011) 151–158.
28. Z. Shen, H. Wang, S.C. Liang, Z.M. Zhang, H.S. Zhang, Spectrofluorimetric deter- mination of reduced glutathione in human blood using N-[p-(2-benzothiazolyl) phe- nyl] maleimide, Anal. Lett. 35 (2002) 2269–2278.
29. Y. Avi-Dor, R. Lipkin, A spectrophotometric method for the determination of reduced glutathione, J. Biol. Chem. 233 (1958) 69–72.
30. M.A. Raggi, L. Nobile, A.G. Giovannini, Spectrophotometric determination of glu-tathione and of its oxidation product in pharmaceutical dosage forms, J. Pharm. Biomed. Anal. 9 (1991) 1037–1040.