Validation of assay procedure of rizatriptan bioequivalence studies of generics according to biowaiver procedure
Keywords:Rizatriptan, validation, liquid chromatography, bioequivalence, biowaiver, pH-dependent solubility, dissolution in vitro
Topicality. Proof of bioequivalence of generic and reference drugs according to biovaser procedure based on the BCS for simplified registration provides for determination of solubility of active substance for establishing the BCS class and kinetics of its release from test drugs in three buffer media. These studies should be carried out according to developed and validated assay methods of active substance.Aim. To establish validation performance of assay methods of Rizatriptan in a complex of studies on determination of bioequivalence of Rizatriptan drugs in form of tablets 5 mg and 10 mg according to biowaiver procedure.
Materials and methods. Validation was carried out for assay methods of Rizatriptan simultaneously studying pH-dependent solubility and kinetics of release of active substance from generic and reference drugs in three buffer media. The study was performed in range of 25-125 % of nominal content of Rizatriptan in test solution in accordance with requirements of SPU in three buffer media according to main validation parameters: full predictable uncertainty of analysis results, specificity, accuracy, repeatability, linearity.
Results and discussion. Correspondence of validation performance to the acceptance criteria in all dissolution media was established.
Conclusions. Based on results of validation, it was justified and experimentally proved that assay methods of Rizatriptan are suitable for analytical support of in vitro bioequivalence studies of MP containing Rizatriptan.
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