Development of an advanced strategy on the assay method transfer

Authors

  • Natalia Volovyk State Enterprise “Ukrainian Scientific Pharmacopoeia Center for the Quality of Medicines” Astromonichna str., 33, Kharkiv, Ukraine, 61085, Ukraine https://orcid.org/0000-0002-9660-8162
  • Dmytro Leontiev State Enterprise “Ukrainian Scientific Pharmacopoeia Center for the Quality of Medicines” Astromonichna str., 33, Kharkiv, Ukraine, 61085 National University of Pharmacy Pushkinska str., 53, Kharkiv, Ukraine, 61002, Ukraine https://orcid.org/0000-0003-1129-8749
  • Vasyl Petrus National University of Pharmacy 53, Pushkinska Str., Kharkiv, Ukraine, 61002 PJSC SIC «Borshcha hivskiy CPP» Myru str., 17, Kyiv, Ukraine, 03134, Ukraine https://orcid.org/0000-0002-9380-8927
  • Oleksandr Gryzodub State Enterprise “Ukrainian Scientific Pharmacopoeia Center for the Quality of Medicines” Astromonichna str., 33, Kharkiv, Ukraine, 61085, Ukraine https://orcid.org/0000-0002-6029-7825
  • Yurii Pidpruzhnykov LLC "Chemical company" Spoluka " Murmanska str., 5, Kyiv, Ukraine, 02660, Ukraine https://orcid.org/0000-0001-6923-0806

DOI:

https://doi.org/10.15587/2519-4852.2020.221721

Keywords:

analytical procedure transfer, lifecycle, acceptance criteria, measurement uncertainty, desloratadine tablets

Abstract

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

Dmytro Leontiev, State Enterprise “Ukrainian Scientific Pharmacopoeia Center for the Quality of Medicines” Astromonichna str., 33, Kharkiv, Ukraine, 61085 National University of Pharmacy Pushkinska str., 53, Kharkiv, Ukraine, 61002

Doctor of Pharmaceutical Sciences, Senior Researcher, Head of Department

Department of Validation and Reference Standards

Professor

Department of Pharmaceutical Chemistry

Vasyl Petrus, National University of Pharmacy 53, Pushkinska Str., Kharkiv, Ukraine, 61002 PJSC SIC «Borshcha hivskiy CPP» Myru str., 17, Kyiv, Ukraine, 03134

Postgraduate Student

Department of Pharmaceutical Chemistry

Engineer

Research and Implementation Laboratory

Oleksandr Gryzodub, State Enterprise “Ukrainian Scientific Pharmacopoeia Center for the Quality of Medicines” Astromonichna str., 33, Kharkiv, Ukraine, 61085

Doctor of Chemical Sciences, Professor, Chief Researcher

Department of State Pharmacopoeia of Ukraine

Yurii Pidpruzhnykov, LLC "Chemical company" Spoluka " Murmanska str., 5, Kyiv, Ukraine, 02660

Doctor of Pharmaceutical Sciences, Professor, Chief Researcher

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Published

2020-12-30

How to Cite

Volovyk, N., Leontiev, D., Petrus, V., Gryzodub, O., & Pidpruzhnykov, Y. (2020). Development of an advanced strategy on the assay method transfer. ScienceRise: Pharmaceutical Science, (6 (28), 56–67. https://doi.org/10.15587/2519-4852.2020.221721

Issue

No. 6 (28) (2020)

Section

Pharmaceutical Science

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Copyright (c) 2020 Natalia Volovyk, Dmytro Leontiev, Vasyl Petrus, Oleksandr Gryzodub, Yurii Pidpruzhnykov

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