DEVELOPMENT AND VALIDATION OF SPECTROPHOTOMETRIC METHOD FOR DETERMINATION OF FABOMOTIZOLE DIHYDROCHLORIDE FOR STUDY OF DISSOLUTION PROFILES

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.