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Spectrophotometric Determination of Mesalazine in Pure Form and Pharmaceutical Formulations by Diazotization and Coupling With 2,7-Dihydroxynaphthalene As a New Coupling Agent

Year 2023, , 195 - 203, 01.09.2023
https://doi.org/10.52794/hujpharm.1129852

Abstract

A simple, specific and sensitive spectrophotometric method is presented for the determination of Mesalazine (MZN) based on diazotization in an acidic medium through reaction with sodium nitrite (NaNO2) to form a diazonium salt that coupling reaction in a base medium with 2,7-Dihydroxynaphthalene (DHNP) to form an azo dye. The dye intensity was measured at 501 nm after optimization of the experimental parameters. Beer’s law was applied to the proposed method, valid within a concentration range of 0.25–10 μg.mL-1, and the linear regression was R2 = 0.9974. The limit of detection (LOD), the limit of quantification (LOQ), the molar absorptivity coefficient were 0.074 μg.mL-1,0.249 μg.mL-1 and 1.85x104 L.mol−1.cm−1, respectively. Sandell's sensitivity was 0.0082μg.cm-2. There is no interference from excipients found in the tablet. The data were statistically compared with the British Pharmacopeia using two statistical methods (t-test and F-test).

References

  • [1] Y. Li et al., “Addition of berberine to 5-aminosalicylic acid for treatment of dextran sulfate sodium-induced chronic colitis in C57BL/6 mice,” PLoS One, vol. 10, no. 12, p. e0144101, 2015.
  • [2] O. H. Nielsen and L. K. Munck, “Drug insight: aminosalicylates for the treatment of IBD,” Nat. Clin. Pract. Gastroenterol. Hepatol., vol. 4, no. 3, pp. 160–170, 2007.
  • [1] Y. Li et al., “Addition of berberine to 5-aminosalicylic acid for treatment of dextran sulfate sodium-induced chronic colitis in C57BL/6 mice,” PLoS One, vol. 10, no. 12, p. e0144101, 2015.
  • [2] O. H. Nielsen and L. K. Munck, “Drug insight: aminosalicylates for the treatment of IBD,” Nat. Clin. Pract. Gastroenterol. Hepatol., vol. 4, no. 3, pp. 160–170, 2007.
  • [3] H. H. Abdu-Allah, A. N. El-Shorbagi, S. G. Abdel-Moty, R. El-Awady, and A. A. Abdel-Alim, “5-Aminosalyclic acid (5-ASA): a unique anti-inflammatory salicylate,” Med Chem (Los Angeles), vol. 6, pp. 306–315, 2016.
  • [4] I. M. Balmus, A. Ciobica, A. Trifan, and C. Stanciu, “The implications of oxidative stress and antioxidant therapies in inflammatory bowel disease: clinical aspects and animal models,” Saudi J. Gastroenterol. Off. J. Saudi Gastroenterol. Assoc., vol. 22, no. 1, p. 3, 2016.
  • [5] A. B. Teradale, S. D. Lamani, P. S. Ganesh, B. E. K. Swamy, and S. N. Das, “CTAB immobilized carbon paste electrode for the determination of mesalazine: a cyclic voltammetric method,” Sens. bio-sensing Res., vol. 15, pp. 53–59, 2017.
  • [6] A. G. Tavares Junior, J. T. C. de Araújo, A. B. Meneguin, and M. Chorilli, “Characteristics, properties and analytical/bioanalytical methods of 5-aminosalicylic acid: a review,” Crit. Rev. Anal. Chem., pp. 1–15, 2020.
  • [7] B. Ceylan, E. K. Tekkeli, and C. Önal, “Development of an HPLC method for the determination of mesalazine in human plasma by fluorimetric derivatization and application to a prototype pharmacokinetic study,” J. Fluoresc., pp. 1–7, 2021.
  • [8] A. Prakash, K. D. Lone, A. Shukla, R. Mandloi, and V. Ghosh, “Spectrophotometric estimation of mesalazine in tablet dosage form,” Asian J. Res. Chem., vol. 1, no. 2, pp. 80–82, 2008.
  • [9] E. A. Hamdon, S. A. Zakaria, and N. M. AL-Hamdany, “Spectrophotometric determination of mesalazine with phloroglycinol in pharmaceutical preparation,” Tikrit J. Pure Sci., vol. 17, no. 2, 2012.
  • [10] E. Sohouli, M. S. Karimi, E. M. Khosrowshahi, M. Rahimi-Nasrabadi, and F. Ahmadi, “Fabrication of an electrochemical mesalazine sensor based on ZIF-67,” Measurement, vol. 165, p. 108140, 2020.
  • [11] I. Setayeshfar, H. R. Rajabi, and O. Khani, “Application of flow injection analysis-solid phase extraction based on ion-pair formation for selective preconcentration of trace amount of anti-HIV drug,” Microchem. J., vol. 177, p. 107245, 2022.
  • [12] G. L. Al-Ramadhani and S. Al-Mtioti, “Determination of Mesalazine Spectrophotometry Based on The Charge Transfer Complex n-π Using Reagent p-bromanil,” J. Educ. Sci., vol. 28, no. 2, pp. 71–84, 2019.
  • [13] S. R. Narala and K. Saraswathi, “A NOVEL USE OF OXIDATIVE COUPLING REACTIONS FOR DETERMINATION OF ANTIBIOTIC AND ANTI-INFLAMMATORY DRUGS IN PHARMACEUTICAL FORMULATIONS,” Int. J. Pharm. Sci. Res., vol. 2, no. 2, p. 366, 2011.
  • [14] B. Pharmacopoeia, “British Pharmacopoeia 2009.” British Pharmacopoeia Commission, 2009.
  • [15] S. K. Motwani, S. Chopra, F. J. Ahmad, and R. K. Khar, “Validated spectrophotometric methods for the estimation of moxifloxacin in bulk and pharmaceutical formulations,” Spectrochim. Acta Part A Mol. Biomol. Spectrosc., vol. 68, no. 2, pp. 250–256, 2007.
  • [16] A. K. Moharana, M. Banerjee, S. Panda, and J. N. Muduli, “Development and validation of UV spectrophotometric method for the determination of mesalamine in bulk and tablet formulation,” Int J Pharm Pharm Sci, vol. 3, no. 2, pp. 19–21, 2011.
  • [17] A. V. C. Simionato, M. D. Cantú, and E. Carrilho, “Characterization of metal-deferoxamine complexes by continuous variation method: A new approach using capillary zone electrophoresis,” Microchem. J., vol. 82, no. 2, pp. 214–219, 2006.
  • [18] S. Ashour and R. Kabbani, “Direct spectrophotometric determination of metformin hydrochloride in pure form and in drug formulations,” Anal. Lett., vol. 36, no. 2, pp. 361–370, 2003.
  • [19] A. Boscher, C. Guignard, T. Pellet, L. Hoffmann, and T. Bohn, “Development of a multi-class method for the quantification of veterinary drug residues in feedingstuffs by liquid chromatography-tandem mass spectrometry,” J. Chromatogr. A, vol. 1217, no. 41, pp. 6394–6404, 2010.
  • [20] M. A. Ajeel, A. A. Ajeel, A. M. Nejres, and R. A. Salih, “Assessment of Heavy Metals and Related Impacts on Antioxidants and Physiological Parameters in Oil Refinery Workers in Iraq,” J. Heal. Pollut., vol. 11, no. 31, p. 210907, 2021.
  • [21] D. A. Skoog, F. J. Holler, and S. R. Crouch, Principles of instrumental analysis. Cengage learning, 2017.

Spectrophotometric Determination of Mesalazine in Pure Form and Pharmaceutical Formulations by Diazotization and Coupling With 2,7-Dihydroxynaphthalene As a New Coupling Agent

Year 2023, , 195 - 203, 01.09.2023
https://doi.org/10.52794/hujpharm.1129852

Abstract

A simple, specific and sensitive spectrophotometric method is presented for the determination of Mesalazine (MZN) based on diazotization in an acidic medium through reaction with sodium nitrite (NaNO2) to form a diazonium salt that coupling reaction in a base medium with 2,7-Dihydroxynaphthalene (DHNP) to form an azo dye. The dye intensity was measured at 501 nm after optimization of the experimental parameters. Beer’s law was applied to the proposed method, valid within a concentration range of 0.25–10 μg.mL-1, and the linear regression was R2 = 0.9974. The limit of detection (LOD), the limit of quantification (LOQ), the molar absorptivity coefficient were 0.074 μg.mL-1,0.249 μg.mL-1 and 1.85x104 L.mol−1.cm−1, respectively. Sandell's sensitivity was 0.0082μg.cm-2. There is no interference from excipients found in the tablet. The data were statistically compared with the British Pharmacopeia using two statistical methods (t-test and F-test).

References

  • [1] Y. Li et al., “Addition of berberine to 5-aminosalicylic acid for treatment of dextran sulfate sodium-induced chronic colitis in C57BL/6 mice,” PLoS One, vol. 10, no. 12, p. e0144101, 2015.
  • [2] O. H. Nielsen and L. K. Munck, “Drug insight: aminosalicylates for the treatment of IBD,” Nat. Clin. Pract. Gastroenterol. Hepatol., vol. 4, no. 3, pp. 160–170, 2007.
  • [1] Y. Li et al., “Addition of berberine to 5-aminosalicylic acid for treatment of dextran sulfate sodium-induced chronic colitis in C57BL/6 mice,” PLoS One, vol. 10, no. 12, p. e0144101, 2015.
  • [2] O. H. Nielsen and L. K. Munck, “Drug insight: aminosalicylates for the treatment of IBD,” Nat. Clin. Pract. Gastroenterol. Hepatol., vol. 4, no. 3, pp. 160–170, 2007.
  • [3] H. H. Abdu-Allah, A. N. El-Shorbagi, S. G. Abdel-Moty, R. El-Awady, and A. A. Abdel-Alim, “5-Aminosalyclic acid (5-ASA): a unique anti-inflammatory salicylate,” Med Chem (Los Angeles), vol. 6, pp. 306–315, 2016.
  • [4] I. M. Balmus, A. Ciobica, A. Trifan, and C. Stanciu, “The implications of oxidative stress and antioxidant therapies in inflammatory bowel disease: clinical aspects and animal models,” Saudi J. Gastroenterol. Off. J. Saudi Gastroenterol. Assoc., vol. 22, no. 1, p. 3, 2016.
  • [5] A. B. Teradale, S. D. Lamani, P. S. Ganesh, B. E. K. Swamy, and S. N. Das, “CTAB immobilized carbon paste electrode for the determination of mesalazine: a cyclic voltammetric method,” Sens. bio-sensing Res., vol. 15, pp. 53–59, 2017.
  • [6] A. G. Tavares Junior, J. T. C. de Araújo, A. B. Meneguin, and M. Chorilli, “Characteristics, properties and analytical/bioanalytical methods of 5-aminosalicylic acid: a review,” Crit. Rev. Anal. Chem., pp. 1–15, 2020.
  • [7] B. Ceylan, E. K. Tekkeli, and C. Önal, “Development of an HPLC method for the determination of mesalazine in human plasma by fluorimetric derivatization and application to a prototype pharmacokinetic study,” J. Fluoresc., pp. 1–7, 2021.
  • [8] A. Prakash, K. D. Lone, A. Shukla, R. Mandloi, and V. Ghosh, “Spectrophotometric estimation of mesalazine in tablet dosage form,” Asian J. Res. Chem., vol. 1, no. 2, pp. 80–82, 2008.
  • [9] E. A. Hamdon, S. A. Zakaria, and N. M. AL-Hamdany, “Spectrophotometric determination of mesalazine with phloroglycinol in pharmaceutical preparation,” Tikrit J. Pure Sci., vol. 17, no. 2, 2012.
  • [10] E. Sohouli, M. S. Karimi, E. M. Khosrowshahi, M. Rahimi-Nasrabadi, and F. Ahmadi, “Fabrication of an electrochemical mesalazine sensor based on ZIF-67,” Measurement, vol. 165, p. 108140, 2020.
  • [11] I. Setayeshfar, H. R. Rajabi, and O. Khani, “Application of flow injection analysis-solid phase extraction based on ion-pair formation for selective preconcentration of trace amount of anti-HIV drug,” Microchem. J., vol. 177, p. 107245, 2022.
  • [12] G. L. Al-Ramadhani and S. Al-Mtioti, “Determination of Mesalazine Spectrophotometry Based on The Charge Transfer Complex n-π Using Reagent p-bromanil,” J. Educ. Sci., vol. 28, no. 2, pp. 71–84, 2019.
  • [13] S. R. Narala and K. Saraswathi, “A NOVEL USE OF OXIDATIVE COUPLING REACTIONS FOR DETERMINATION OF ANTIBIOTIC AND ANTI-INFLAMMATORY DRUGS IN PHARMACEUTICAL FORMULATIONS,” Int. J. Pharm. Sci. Res., vol. 2, no. 2, p. 366, 2011.
  • [14] B. Pharmacopoeia, “British Pharmacopoeia 2009.” British Pharmacopoeia Commission, 2009.
  • [15] S. K. Motwani, S. Chopra, F. J. Ahmad, and R. K. Khar, “Validated spectrophotometric methods for the estimation of moxifloxacin in bulk and pharmaceutical formulations,” Spectrochim. Acta Part A Mol. Biomol. Spectrosc., vol. 68, no. 2, pp. 250–256, 2007.
  • [16] A. K. Moharana, M. Banerjee, S. Panda, and J. N. Muduli, “Development and validation of UV spectrophotometric method for the determination of mesalamine in bulk and tablet formulation,” Int J Pharm Pharm Sci, vol. 3, no. 2, pp. 19–21, 2011.
  • [17] A. V. C. Simionato, M. D. Cantú, and E. Carrilho, “Characterization of metal-deferoxamine complexes by continuous variation method: A new approach using capillary zone electrophoresis,” Microchem. J., vol. 82, no. 2, pp. 214–219, 2006.
  • [18] S. Ashour and R. Kabbani, “Direct spectrophotometric determination of metformin hydrochloride in pure form and in drug formulations,” Anal. Lett., vol. 36, no. 2, pp. 361–370, 2003.
  • [19] A. Boscher, C. Guignard, T. Pellet, L. Hoffmann, and T. Bohn, “Development of a multi-class method for the quantification of veterinary drug residues in feedingstuffs by liquid chromatography-tandem mass spectrometry,” J. Chromatogr. A, vol. 1217, no. 41, pp. 6394–6404, 2010.
  • [20] M. A. Ajeel, A. A. Ajeel, A. M. Nejres, and R. A. Salih, “Assessment of Heavy Metals and Related Impacts on Antioxidants and Physiological Parameters in Oil Refinery Workers in Iraq,” J. Heal. Pollut., vol. 11, no. 31, p. 210907, 2021.
  • [21] D. A. Skoog, F. J. Holler, and S. R. Crouch, Principles of instrumental analysis. Cengage learning, 2017.
There are 23 citations in total.

Details

Primary Language English
Subjects Analytical Chemistry
Journal Section Research Articles
Authors

Aws Maseer

Moath Najem

Publication Date September 1, 2023
Acceptance Date May 8, 2023
Published in Issue Year 2023

Cite

Vancouver Maseer A, Najem M. Spectrophotometric Determination of Mesalazine in Pure Form and Pharmaceutical Formulations by Diazotization and Coupling With 2,7-Dihydroxynaphthalene As a New Coupling Agent. HUJPHARM. 2023;43(3):195-203.