Kinetic investigation of Famotidine S-oxidation reaction using potassium caroate. Development and validation of the titrimetric method for the quantitative determination of Famotidine in pure substance and medical preparation

Authors

  • Mykola Yevstahiyovych Blazheyevskiy National University of Pharmacy. Department of Physical and Colloid Chemistry
  • Yulia Yuriivna Serdiukova National University of Pharmacy. Department of Physical and Colloid Chemistry
  • Svitlana Pavlivna Karpova National University of Pharmacy. Department of Physical and Colloid Chemistry
  • Liliya Osypivna Dubenska Ivan Franko National University of Lviv

Keywords:

Kinetics, Mechanism, Oxidation, Famotidine, Potassium caroate

Abstract

Aims: The kinetic studies of Famotidine (FMT) pure substance and medicinal preparation have been carried out in buffer solutions under second-order conditions at the temperature 293 K for the first time. New titrimetric procedures are described for the FMT determination.

Materials and Methods: FMT pure substance and tablets have been used in analytical reaction with of KHSO5. The kinetic behavior has been studied by the iodometric method in different pH medium.

Results: FMT oxidation reaction has been studied for the S-oxide product under pH=2.0-5.0 and Sulfone product under pH=7.0-8.4. The reaction studied corresponds to the total second order. The Sulfone formation from FMT S-oxide reaction rate constant is in the interval from 14.49 to 32 min-1 L mol-1. FMT has been treated with a measured excess of standard potassium caroate in buffer solution with pH 7, after a contact time of 20 min, the residual oxidant back has been determined by the iodometric titration method. The titrimetric method is applicable over 1-10 mg mL-1 concentration range and the reaction follows 1:2 (FMT:KHSO5) stoichiometry. The method has been validated for precision, accuracy, linearity, robustness and LOQ. The recovery percent ranged from 99.2 to 100.5%, RSD from 1.09 to 1.70 %, LOQ = 0.03 mg mL-1 for pure substance. RSD for tablet formulations has been in the limits from 1.17-2.87 %.

Conclusions: The conditions of FMT S-oxide and Sulfone formation have been optimized. The developed procedures are rapid, simple and inexpensive and could be applied to pharmaceutical preparation.

Downloads

Download data is not yet available.

References

Mohamed AA, Abdullah MA. Famotidine. Profiles of Drug Substances, Excipients, and Related Methodology. 2009; 34: 116-150. doi: 10.1016.S1871-5125(09)34003-0.

British Pharmacopoeia. The Stationary Office London. 1998; 572.

U.S. Pharmacopoeia 30-NF25, National Formulary 25, Pharmacopoeial Convention: Rockville. 2008; 2137.

Amin AS, Shama SA, Ahmed IS, Gouda EA. Spectrophotometric determination of famotidine through oxidation with n-bromosuccinimide and cerric sulphate. Analytical Letters. 2002; 35(11): 1851-1862. doi: 10.1081/AL-120013588]

Reddy NR, Prabhavathi K, Bhaskar Reddy YV, Chakravarthy IE. A new spectrophotometric determination of famotidine from tablets. Indian Journal of Pharmaceutical Sciences 2006; 68: 645-647.

Kanakapura B, Okram Z. Spectrophotometric determination of famotidine using sulphonphthalein dyes. Quim. Nova. 2011; 34(5):735-742.

Tsvetkova B, Maslarska V, Peikova L. An overview of Determination of Famotidine by different analytical methods. Pharmacia. 2015; 62 (1): 12-24

Zendelovska D, Stafilov T. High-performance liquid chromatographic determination of famotidine in human plasma using solid-phase column extraction. Journal of the Serbian Chemical Society 2003; 68 (11): 883-892.

Zarghi A, Shafaati A, Foroutan S, Khoddam A. Development of a rapid HPLC method for determination of famotidine in human plasma using a monolithic column. Journal of Pharmaceutical and Biomedical Analysis 2005; 39 (3-4): 677680.

Myhal AV, Marksa M, Golovchenko OS, Georgiyants VA, Ivanauskas L. Comparison of chromatographic methods of analysis in a thin layer of the sorbent for identification of famotidine in tablets. Vìsnik Farmacìï. 2017; 2 (90): 21-24.

Basavaiah K, Prameela HC, Chandrashekar U, Somashekar BC. High Performance Liquid Chromatographic Assay Of Famotidine In Pharmaceuticals. Analytical chemistry an Indian Journal. 2006; 5(2-3): 94-98

Helali N, Tran N, Monser L, Taverna M. Capillary zone electrophoresis method for the determination of famotidine and related impurities in pharmaceuticals. Talanta 2008; 74 (4): 694-698.

Ayad MM, Shalaby A, Abdellatef HE, Elsaid HM. Potentiometric determination of famotidine in pharmaceutical formulations. Journal of Pharmaceutical and Biomedical Analysis. 2002; 29: 247–254.

Walash MI, Sharaf-El-Din MK, El-Sayed MM, Shabana MR. Polarographic determination of famotidine through complexation with Nickel (II) chloride. Journal of the Chinese Chemical Society. 2005; 52: 927.

Skrzypek S, Ciesielski W, Sokolowski A, Yilmaz S, Kazmierczak D. Square wave adsorptive stripping voltammetric determination of famotidine in urine. Talanta. 2005; 66: 1146-1151.

Yagmur S, Yilmaz S, Saglikoglu G, Uslu B, Sadikoglu M, Ozkan SA. Sensitive voltammetric determination of famotidine in human urine and tablet dosage forms using an ultra trace graphite electrode. J. Serb. Chem. Soc. 2014; 79 (1):53–62.

David IG, Popa DE, Calin AA, Buleandra M, Iorgulescu EE. Voltammetric determination of famotidine on a disposable pencil graphite electrode. Turk J Chem. 2016; 40: 125 – 135. doi:10.3906/kim-1504-42.

Basavaiah K, Prameela HC. Titrimetric and spectrophotometric determination of famotidine using chloramine-T. Bulgarian chemical communications. 2003; 35 (1): 37-42.

Price JS, Tasker IR, Appelman EH, O’Hare PAG Thermochemistry of inorganic sulfur compounds IX. Molar heat capacity of KHSO5(cr) from 5 to 300 K, and the partial molar entropy of HSO5-(aq). The journal of chemical thermodynamics. 1986; 18 (10): 923-930.

http://chem.lnu.edu.ua/mtech/devices.htm

Validation of Analyical Procedures, Proceedinds of the International Conference on Harmonisation (ICH). Commission of the European Communities; 1996.

Vijayaraj S, Omshanthi B, Anitha S, Perumal K, Kumar S. Synthesis and Characterization of Novel Sulphoxide prodrug of Famotidine. Indian Journal of Pharmaceutical Education and Research. 2014; 48(4): 35-44. doi: 10.5530/ijper.48.4.6.

Bennett DA, Yao H, Richardson DE. Mechanism of Sulfide Oxidations by Peroxymonocarbonate. Inorg. Chem. 2001; 40 (13): 2996–3001. doi: 10.1021/ic000910h.

Ball DL, Edwards JO. The kinetics and mechanism of the decomposition of Caro’s acid. I. Contribution from the Metcalf chemical laboratories of Brown University. 1956; 78: 1125-1129.

Pylypchuk OA, Zinchuk VK, Sushyntseva NM, Vasylechko VO. Doslidgennya stabil’nosti rozavedenych rozchyniv kysloty karo. Lviv un. 1996; 62 (2): 122-123.

Downloads

Published

2018-06-20

How to Cite

1.
Blazheyevskiy MY, Serdiukova YY, Karpova SP, Dubenska LO. Kinetic investigation of Famotidine S-oxidation reaction using potassium caroate. Development and validation of the titrimetric method for the quantitative determination of Famotidine in pure substance and medical preparation. Ars Pharm [Internet]. 2018 Jun. 20 [cited 2024 Jul. 22];59(2):69-76. Available from: https://revistaseug.ugr.es/index.php/ars/article/view/7514

Issue

Vol. 59 No. 2 (2018)

Section

Original Articles

License

The articles, which are published in this journal, are subject to the following terms in relation to the rights of patrimonial or exploitation:

  1. The authors will keep their copyright and guarantee to the journal the right of first publication of their work, which will be distributed with a Creative Commons BY-NC-SA 4.0 license that allows third parties to reuse the work whenever its author, quote the original source and do not make commercial use of it.

b. The authors may adopt other non-exclusive licensing agreements for the distribution of the published version of the work (e.g., deposit it in an institutional telematic file or publish it in a monographic volume) provided that the original source of its publication is indicated.

c. Authors are allowed and advised to disseminate their work through the Internet (e.g. in institutional repositories or on their website) before and during the submission process, which can produce interesting exchanges and increase citations of the published work. (See The effect of open access).