Development of Spectrophotometric Method for The Determination of Mesalazine as Pure Form and in Tablets

Year 2023, Volume: 5 Issue: 3, 101 - 111, 31.12.2023

Eman Bahjat , Salim Ali Dheyaa Thamer Azeez

https://doi.org/10.59124/guhes.1182761

Abstract

This method involves development of a highly sensitive spectrophotometric procedure to estimate mesalazine as pure substance and in the tablets. This particular procedure was focused on the diazotization of mesalazine with an excess quantity of sodium nitrite (NaNO2) in an acid medium using HCl solution to produce a corresponding diazonium compound which reacts with 8-hydroxyquinoline reagent in an alkaline solution of NaOH to yield read-orange azo dye which is soluble in water and showed maximum absorption peak at the wavelength of 500 nm against the blank solution. The calibration graph was linear and compatible to Beer's law over the concentration range from 0.25 to 12.5 μg/ml with an exceptional determination coefficient (R2= 0.9994) and apparent molar absorptivity 2.88 × 104 L.mol-1cm-1. The limits of detection (LOD) and quantitation (LOQ) were premeditated and found to be 0.2023 and 0.6524 μg/ml, correspondingly. A relative error percent (accuracy) and the relative standard deviation (RSD%) was also calculated and found to be in the range -3.84% - 2.70%, and 0.17% - 1.94%, correspondingly. No interferences were observed from other ingredients that may be exist in the tablets. The stoichiometry of the resulting azo dye has been examined and the experimental results revealed that the mole ratio of mesalazine to 8-hydroxyquinoline is 1:1. The advised procedure was successfully applied for the determination of mesalazine in its pharmaceutical form (tablets).

Keywords

diazotization and coupling reaction, mesalazine, spectrophotometry, 8-hydroxyquinoline

Supporting Institution

Mosul university

References

• Al-Ramadhani, G.O., & Al-Mtioti S. (2019). Determination of mesalazine spectrophotometry based on the charge transfer complex n- π using reagent p-bromanil. Journal of Education And Science, 28 (2), 71-84. http://dx.doi.org/10.33899/edusj.2019.161178
• Altayib, F., Abdalla, A., & Elbashir, A.A., (2014). Development and validation of spectrophot-ometric methods for the determination of mesalazine in pharmaceutical formulation. Medicinal Chemistry, 4 (3), 361-366. http://dx.doi.org/10.4172/2161-0444.1000166
• Anumolu, P.D., Gurrala, S., Gellaboina, A., Mangipudi, D. G., Menkana, S., & Chakka, R. (2019). Spectrophotometric quantification of anti-inflammatory drugs by application of chromogenic reagents. Turkish Journal of Pharmaceutical Sciences, 16 (4), 410-415. http://dx.doi.org/10.4274/tjps.galenos.2018.07830
• Aziz, A. T. & Sultan, S. H. (2019). Spectrophotometric determination of mesalazine in pharmaceutical preparations by diazotization and coupling with 2,6-dihydroxytoluene as a new coupling Agent. Raf. J. Sci., 28 (2): 47-55 https://scholar.google.com/scholarhl=ar&as_sdt=0%2C5&q=DOI%3A+10.33899%2Frjs.2019.159966&oq=
• British pharmacopoeia (2013). CD-Rom. Ed. System Simulation Ltd., the stationary office, London.
• Cartwright, A.C. (2016). The British pharmacopoeia, 1864 to 2014: medicines, international standards and the state. Routledge.
• Clayden, J., Greeves, N., Warren, S., & Wothers, P. (2001). "Organic Chemistry". 2nd ed., Oxford University Press, London, pp. 1056-1057. (ISBN: 978-0-19-927029-3)
• Delevie, R.. (1997). Principles of Quantitative Chemical Analysis, International Edn., The McGraw-Hill company, Singapore, p 498. (ISBN: 0071142886, 9780071142885)
• Guang Y., Song, D., Du, A., Zheng, J., Gao, H., Qi, X., Jiang, W., Gong, Z., & Teng, J. (2015). Determination of mesalazine using terbium rare earth ions as a fluorescence probe. International Conference on Material Science and Application. https://dx.doi.org/10.2991/icmsa-15.2015.10
• Hamdon, E.A., Zakaria, S.A. & AL-Hamdany, N.M. (2012). Spectrophotometric determination of mesalazine with phloroglycinol in pharmaceutical preparation, Tikrit Journal of Pure Science, 17 (2), 133-137.
• Kumar, A.A., Rani, T.S., Ganesh, P.S. & Swamy, B.E.K. (2017). Electrochemical oxidation of mesalazine drug at poly (glutamic acid) modified glassy carbon electrode. Analytical and Bioanalytical Electrochemistry, 9 (3), 328-339.
• Madhavi, V., Panchakshari, V., Prathyusha, Th. N. & Sekaran, Ch. B. (2011). Spectrophotometric determination of mesalazine in bulk and tablet dosage forms based on diazocoupling reaction with resorcinol. International Journal of Pharmaceutical Sciences Review and Research., 11 (1), 105-109.
• Nair, S. G., Shah, J. V., Shah, P. A., Sanyal, M., Shrivastav, P. S. (2015). Extractive spectrophot-ometric determination of five selected drugs by ion-pair complex formation with bromothymol blue in pure form and pharmaceutical preparations, Cogent Chemistry, 1, 1-14. https://doi.org/10.1080/23312009.2015.1075852
• Pasternak, B., Svanström, H., Mølgaard-Nielsen, D., Melbye, M. & Hviid, A. (2013). Metoclopramide in Pregnancy and Risk of Major Congenital Malformations and Fetal Death. Journal Of The American Medical Association, 310, 1601–1611. http://dx.doi.org/10.1001/jama.2013.278343
• Rao, K.H. & Sekhar, K. B. C. (2013). Validated RP-HPLC method for the estimation of mesalamine in bulk and tablet dosage form. International J. Research in Pharm. Chem. 3 (2), 472-476.
• Salih, E. S. & Mohammed, A. (2020). Spectrophotometric assay of mesalazine in pharmaceutical preparations via oxidative coupling reaction with o-cresol and sodium metaperiodate. J. Ed. Sci. 29 (1), 279-292. http://dx.doi.org/10.33899/edusj.2020.172815
• Sama, N.S., Gurupadayya, B. M. & Kumar, C.A. (2011). Spectrophotometric determination of mesalamine by PDAC and NQS reagents in bulk and tablet dosage form. Journal of Pharmacy Research. 4 (1), 39-41.
• Shehab, A. A. & Muhammed, D. H. (2020). Spectrophotometric determination of mesalazine via oxidative coupling reaction. Sys Rev Pharm. 11 (6), 922–929. https://doi.org/10.21123/bsj.2019.16.4(Suppl.).1010
• Shihab, I. A. (2011). Spectrophotometric determination of mesalazine via oxidative coupling reaction. Tikrit J. Pur. Sic. 16 (4), 64-69.
• Tanuja, S. B., Swamy, B. E. K. & Pai, K.V. (2018). Electrochemical studies of mesalazine at sodium dodecyl sulfate modified carbon paste electrode: A cyclic voltammetric study. Anal. Bioanal. Electrochem. 10 (1), 64-76.
• Zakaria, S. A. (2019). Spectrophotometric Determination of Mesalazine. Raf. J. Sci. 28 (2), 127-134. http://dx.doi.org/10.33899/rjs.2019.159982
• Zakaria, R.A. (2013). Spectrophotometric determination of mesalazine by 8-Hydrox-yquinoline and N-(1-naphthyl)ethylenediamine. dihydrochloride reagents in bulk and capsule dosage forms. Raf. J. Sci. 24 (1), 146-158. http://dx.doi.org/10.33899/rjs.2013.67591
• Zawada, E., Chaber, E. P., R Somogi, A. & Pawinski, T. (2017). Development and validation of bromatometric, diazotization and vis-spectrophotometric methods for the determination of mesalazine in pharmaceutical formulation. Acta Poloniae Pharmaceutica - Drug Research. 74 (2), 401-404 .
• Zayed, M. A. & Farrag, Y. S. (2016). Spectroscopic studies and applications of the reactions of some anti-diabetic and anti-hypertensive drugs with rose bengal. Pharm Anal Acta. 7 (503), 2. http://dx.doi.org/10.4172/2153-2435.1000503