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Aim. The paper intends to frame and pilot the optimised science-based principles of the assay transfer. Materials and methods. The research was performed on desloratadine film-coated tablets, using an analytical balance Mettler Toledo XP 205DR and Class A volumetric glassware. Absorbance readings were measured on a UV-Vis spectrophotometer Lambda 25. Results and discussion. The concept of method transfer that complements the conventional approach to validation with the lifecycle initiative and the metrological base of the State Pharmacopoeia of Ukraine was substantiated, following which the transfer of the spectrophotometric procedure for desloratadine assay was conducted. For the batch intended for the transfer, the budget of analytical and technological variability was balanced. The deviation of a single assay result from the grand mean was used as the criterion for accuracy in the transfer. The requirement for the one-sided confidence interval for assay result runs not to exceed the target uncertainty of the procedure was used as the criterion for precision. The control strategy requirements for variability sources and the analytical target profile requirements for precision and accuracy were met in the receiving unit.Conclusion. The paper discusses the premise and advocates an alternative approach to the method transfer. Precision is proposed not to study during the transfer (in the short-term experiment) but assess from the stability data (in the long-term experiment). Compliance with the normal analytical practice (the maximum permissible variability attributed to analysts and analytical instruments) allows narrowing down the transfer design to the confirmation in the minimal experiment that the amplitude of variability sources lies within the predefined range Author Biographies Natalia Volovyk, State Enterprise “Ukrainian Scientific Pharmacopoeia Center for the Quality of Medicines” Astromonichna str., 33, Kharkiv, Ukraine, 61085 PhD Department of Validation and Reference Standards

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