Verification of “Dissolution” Test for Famotidine Tablets with UV-spectrophotometric Determination

Artem Myhal; Olga Golovchenko; Svitlana Gubar; Victoriya Georgiyants

doi:doi:10.11648/j.pst.20170101.13

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Verification of “Dissolution” Test for Famotidine Tablets with UV-spectrophotometric Determination

Artem Myhal, Olga Golovchenko, Svitlana Gubar, Victoriya Georgiyants

Published in Pharmaceutical Science and Technology (Volume 1, Issue 1)

Received: 31 October 2016 Accepted: 6 December 2016 Published: 5 January 2017

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Abstract

Famotidine is a new generation of antiulcer drugs. There are 14 different dosage forms are registered in Ukraine, and 50% of them are produced by Ukrainian pharmaceutical factories. That is why it is necessary to include into the first supplement of the second edition of the State Pharmacopeia of Ukraine monographs for regulating quality control of dosage forms with famotidine. Methods of quality control for famotidine tablets are present in the United States Pharmacopeia, and do not require complete validation procedure, but only their verification. The USP method for “Dissolution” test for famotidine tablets with UV-spectrophotometry determination was verified for including to the State Pharmacopeia of Ukraine. Specificity, linearity, convergence, as well as the accuracy were determined for this method and confirmed its correctness. The total uncertainty of the method is 1.12% that not more than critical value of total uncertainty for the “Dissolution” test (3.00%).

Published in	Pharmaceutical Science and Technology (Volume 1, Issue 1)
DOI	10.11648/j.pst.20170101.13
Page(s)	6-9
Creative Commons	This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.
Copyright	Copyright © The Author(s), 2017. Published by Science Publishing Group

Keywords

Famotidine Tablets, Verification, Dissolution, UV-spectrophotometry

References

[1]	British Pharmacopoeia 2009 / London. The Stationary Office. – 2008. – Vol. 1-4. – pp. 8826-8829.
[2]	European Pharmacopoeia eighth edition. Directorate for the Quality of Medicines & HealthCare of the Council of Europe (EDQM). – 2013. – pp. 2211-2212.
[3]	Gryzodub O. I., Standard procedures for the validation of methods of quality control of medicines. Kharkiv: Farmakom, 2006; 1/2, pp. 35-44.
[4]	Guide 42-7.1:2014. Guidelines on Clinical Research. Drugs. Investigation of Bioavailability. Kyiv:MPHU; 2014.
[5]	Ivashkin V. T., Lapina T. L., et al. Rational pharmacotherapy of diseases of the digestive system. Moscow:Literra; 2003 – 16 p.
[6]	Pharmacist’s protocols / edited by VP Chernykh, IA Zupanets, OM Lischyshyna – Kharkiv: Golden Pages, 2014. – 232 p.
[7]	State Pharmacopoeia of Ukraine, 2nd ed., vol.1. State Enterprise "Ukrainian scientific pharmacopoeia center of quality of medicines", 2015; pp. 910-930.
[8]	Unified clinical protocols of primary, secondary (specialized) medical care for peptic ulcer of the stomach and duodenum in adults. Available from: http://www.dec.gov.ua/mtd/_peptychvyrazka
[9]	United States Pharmacopeia 37, 2014. – USP Convention Inc. – [Electronic version].
[10]	Zupanets I. A., Chernykh V. P., Kupnovytska I. G., et al. Clinical pharmacy. Kharkiv: Golden pages; 2013. – 970 p.

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APA Style

Artem Myhal, Olga Golovchenko, Svitlana Gubar, Victoriya Georgiyants. (2017). Verification of “Dissolution” Test for Famotidine Tablets with UV-spectrophotometric Determination. Pharmaceutical Science and Technology, 1(1), 6-9. https://doi.org/10.11648/j.pst.20170101.13

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ACS Style

Artem Myhal; Olga Golovchenko; Svitlana Gubar; Victoriya Georgiyants. Verification of “Dissolution” Test for Famotidine Tablets with UV-spectrophotometric Determination. Pharm. Sci. Technol. 2017, 1(1), 6-9. doi: 10.11648/j.pst.20170101.13

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AMA Style

Artem Myhal, Olga Golovchenko, Svitlana Gubar, Victoriya Georgiyants. Verification of “Dissolution” Test for Famotidine Tablets with UV-spectrophotometric Determination. Pharm Sci Technol. 2017;1(1):6-9. doi: 10.11648/j.pst.20170101.13

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@article{10.11648/j.pst.20170101.13,
  author = {Artem Myhal and Olga Golovchenko and Svitlana Gubar and Victoriya Georgiyants},
  title = {Verification of “Dissolution” Test for Famotidine Tablets with UV-spectrophotometric Determination},
  journal = {Pharmaceutical Science and Technology},
  volume = {1},
  number = {1},
  pages = {6-9},
  doi = {10.11648/j.pst.20170101.13},
  url = {https://doi.org/10.11648/j.pst.20170101.13},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.pst.20170101.13},
  abstract = {Famotidine is a new generation of antiulcer drugs. There are 14 different dosage forms are registered in Ukraine, and 50% of them are produced by Ukrainian pharmaceutical factories. That is why it is necessary to include into the first supplement of the second edition of the State Pharmacopeia of Ukraine monographs for regulating quality control of dosage forms with famotidine. Methods of quality control for famotidine tablets are present in the United States Pharmacopeia, and do not require complete validation procedure, but only their verification. The USP method for “Dissolution” test for famotidine tablets with UV-spectrophotometry determination was verified for including to the State Pharmacopeia of Ukraine. Specificity, linearity, convergence, as well as the accuracy were determined for this method and confirmed its correctness. The total uncertainty of the method is 1.12% that not more than critical value of total uncertainty for the “Dissolution” test (3.00%).},
 year = {2017}
}

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TY  - JOUR
T1  - Verification of “Dissolution” Test for Famotidine Tablets with UV-spectrophotometric Determination
AU  - Artem Myhal
AU  - Olga Golovchenko
AU  - Svitlana Gubar
AU  - Victoriya Georgiyants
Y1  - 2017/01/05
PY  - 2017
N1  - https://doi.org/10.11648/j.pst.20170101.13
DO  - 10.11648/j.pst.20170101.13
T2  - Pharmaceutical Science and Technology
JF  - Pharmaceutical Science and Technology
JO  - Pharmaceutical Science and Technology
SP  - 6
EP  - 9
PB  - Science Publishing Group
SN  - 2640-4540
UR  - https://doi.org/10.11648/j.pst.20170101.13
AB  - Famotidine is a new generation of antiulcer drugs. There are 14 different dosage forms are registered in Ukraine, and 50% of them are produced by Ukrainian pharmaceutical factories. That is why it is necessary to include into the first supplement of the second edition of the State Pharmacopeia of Ukraine monographs for regulating quality control of dosage forms with famotidine. Methods of quality control for famotidine tablets are present in the United States Pharmacopeia, and do not require complete validation procedure, but only their verification. The USP method for “Dissolution” test for famotidine tablets with UV-spectrophotometry determination was verified for including to the State Pharmacopeia of Ukraine. Specificity, linearity, convergence, as well as the accuracy were determined for this method and confirmed its correctness. The total uncertainty of the method is 1.12% that not more than critical value of total uncertainty for the “Dissolution” test (3.00%).
VL  - 1
IS  - 1
ER  -

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Author Information

Artem Myhal

Pharmaceutical Chemistry Department, National University of Pharmacy, Kharkiv, Ukraine
Olga Golovchenko

Pharmaceutical Chemistry Department, National University of Pharmacy, Kharkiv, Ukraine
Svitlana Gubar

Pharma
Victoriya Georgiyants

Pharmaceutical Chemistry Department, National University of Pharmacy, Kharkiv, Ukraine

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Plain Text BibTeX RIS

APA Style

Artem Myhal, Olga Golovchenko, Svitlana Gubar, Victoriya Georgiyants. (2017). Verification of “Dissolution” Test for Famotidine Tablets with UV-spectrophotometric Determination. Pharmaceutical Science and Technology, 1(1), 6-9. https://doi.org/10.11648/j.pst.20170101.13

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ACS Style

Artem Myhal; Olga Golovchenko; Svitlana Gubar; Victoriya Georgiyants. Verification of “Dissolution” Test for Famotidine Tablets with UV-spectrophotometric Determination. Pharm. Sci. Technol. 2017, 1(1), 6-9. doi: 10.11648/j.pst.20170101.13

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AMA Style

Artem Myhal, Olga Golovchenko, Svitlana Gubar, Victoriya Georgiyants. Verification of “Dissolution” Test for Famotidine Tablets with UV-spectrophotometric Determination. Pharm Sci Technol. 2017;1(1):6-9. doi: 10.11648/j.pst.20170101.13

Copy | Download

@article{10.11648/j.pst.20170101.13,
  author = {Artem Myhal and Olga Golovchenko and Svitlana Gubar and Victoriya Georgiyants},
  title = {Verification of “Dissolution” Test for Famotidine Tablets with UV-spectrophotometric Determination},
  journal = {Pharmaceutical Science and Technology},
  volume = {1},
  number = {1},
  pages = {6-9},
  doi = {10.11648/j.pst.20170101.13},
  url = {https://doi.org/10.11648/j.pst.20170101.13},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.pst.20170101.13},
  abstract = {Famotidine is a new generation of antiulcer drugs. There are 14 different dosage forms are registered in Ukraine, and 50% of them are produced by Ukrainian pharmaceutical factories. That is why it is necessary to include into the first supplement of the second edition of the State Pharmacopeia of Ukraine monographs for regulating quality control of dosage forms with famotidine. Methods of quality control for famotidine tablets are present in the United States Pharmacopeia, and do not require complete validation procedure, but only their verification. The USP method for “Dissolution” test for famotidine tablets with UV-spectrophotometry determination was verified for including to the State Pharmacopeia of Ukraine. Specificity, linearity, convergence, as well as the accuracy were determined for this method and confirmed its correctness. The total uncertainty of the method is 1.12% that not more than critical value of total uncertainty for the “Dissolution” test (3.00%).},
 year = {2017}
}

Copy | Download

TY  - JOUR
T1  - Verification of “Dissolution” Test for Famotidine Tablets with UV-spectrophotometric Determination
AU  - Artem Myhal
AU  - Olga Golovchenko
AU  - Svitlana Gubar
AU  - Victoriya Georgiyants
Y1  - 2017/01/05
PY  - 2017
N1  - https://doi.org/10.11648/j.pst.20170101.13
DO  - 10.11648/j.pst.20170101.13
T2  - Pharmaceutical Science and Technology
JF  - Pharmaceutical Science and Technology
JO  - Pharmaceutical Science and Technology
SP  - 6
EP  - 9
PB  - Science Publishing Group
SN  - 2640-4540
UR  - https://doi.org/10.11648/j.pst.20170101.13
AB  - Famotidine is a new generation of antiulcer drugs. There are 14 different dosage forms are registered in Ukraine, and 50% of them are produced by Ukrainian pharmaceutical factories. That is why it is necessary to include into the first supplement of the second edition of the State Pharmacopeia of Ukraine monographs for regulating quality control of dosage forms with famotidine. Methods of quality control for famotidine tablets are present in the United States Pharmacopeia, and do not require complete validation procedure, but only their verification. The USP method for “Dissolution” test for famotidine tablets with UV-spectrophotometry determination was verified for including to the State Pharmacopeia of Ukraine. Specificity, linearity, convergence, as well as the accuracy were determined for this method and confirmed its correctness. The total uncertainty of the method is 1.12% that not more than critical value of total uncertainty for the “Dissolution” test (3.00%).
VL  - 1
IS  - 1
ER  -

Copy | Download