Validation of the spectrophotometric method of the determination of sildenafil citrate in tablet form
Abstract
The express spectrophotometric method of quantitative determination of sildenafil citrate in tablets «Intagra» (JV «InterChem») has been developed and validated. Values of constants of ionisation sildenafil (pK1 = 3,66, pK2 = 5,17 and pK3 = 10,03) have been calculated. To confirm the bioequivalence by comparative researches in vitro the determination of dissolution profiles of the drug-generic «Intagra» (JV «InterChem) and a referent drug «Viagra» («Pfizer») in three media with values of pH 1,2; pH 4,5 and pH 6,8 has been spent. Values of factors of similarity f2 which values testify to equivalence of drugs have been calculated.
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