Abstract
Establishing the biopharmaceutical equivalence of generic drugs is a necessary component of the relevant drug dossier. Determination of in vitro equivalence is a test designed to assess the equivalence of the dissolution profiles of the study and reference drugs in three dissolution media with pH values of 1.2; 4.5 and 6.8. A value of f2 in the range from 50 to 100 guarantees the similarity or equivalence of the two profiles and the equivalence of the pharmacological action of the test drug and the reference drug. A method for the quantitative determination of the fabomotizole dihydrochloride by spectrophotometric method has been developed, which is suitable for studying the dissolution profiles of BAFAZOL IC tablets, 10 mg tablets. Measure the absorbance of the test solution and the reference solution in a 1 cm cell relative to the compensation solution at wavelength: 302 nm for 0.1 M hydrochloric acid solution and 296 nm for acetate buffer pH 4.5 and phosphate buffer pH 6 8. The method was validated on the parameters of specificity, accuracy, correctness, linearity in the studied range of concentrations. Excipients do not interfere on the determination of the fabomotizole dihydrochloride. The absorption spectra of the test solution and the reference solution coincide in nature and position of the maximum. This also confirms the specificity of the method. Linearity was investigated on model mixtures in different dissolution media inthe range of 10. – 130%. The coefficients of linear dependences in the studied concentration ranges correspond to the allowable values. The stability of the tested solutions and reference solutions in the case of their storage at room temperature for 8 hours was confirmed. The release of more than 85% of fabomotizole dihydrochloride in 15 min in all dissolution media indicates the similarity of the dissolution profiles and does not require the calculation of the similarity factor f2.
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