Volume 1, Issue 1, June 2017, Page: 6-9
Verification of “Dissolution” Test for Famotidine Tablets with UV-spectrophotometric Determination
Artem Myhal, Pharmaceutical Chemistry Department, National University of Pharmacy, Kharkiv, Ukraine; State scientific-Research Laboratory for Medicinal Substances Quality Control, National University of Pharmacy, Kharkiv, Ukraine
Olga Golovchenko, Pharmaceutical Chemistry Department, National University of Pharmacy, Kharkiv, Ukraine
Svitlana Gubar, Pharma; State scientific-Research Laboratory for Medicinal Substances Quality Control, National University of Pharmacy, Kharkiv, Ukraineeutical Chemistry Department, National University of Pharmacy, Kharkiv, Ukraine
Victoriya Georgiyants, Pharmaceutical Chemistry Department, National University of Pharmacy, Kharkiv, Ukraine
Received: Oct. 31, 2016;       Accepted: Dec. 6, 2016;       Published: Jan. 5, 2017
DOI: 10.11648/j.pst.20170101.13      View  2229      Downloads  74
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%).
Keywords
Famotidine Tablets, Verification, Dissolution, UV-spectrophotometry
To cite this article
Artem Myhal, Olga Golovchenko, Svitlana Gubar, Victoriya Georgiyants, Verification of “Dissolution” Test for Famotidine Tablets with UV-spectrophotometric Determination, Pharmaceutical Science and Technology. Vol. 1, No. 1, 2017, pp. 6-9. doi: 10.11648/j.pst.20170101.13
Copyright
Copyright © 2017 Authors retain the copyright of this article.
This article is an open access article distributed under the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/) which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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