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

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%).