INVESTIGATION OF ROBUSTNESS AT VALIDATION OF HPLC AND UPLC METHODS: A MODERN APPROACH INCLUDING RISK ANALYSIS

A new approach to the robustness investigation of HPLC/UPLC methods that includes use of risk analysis is offered. It allows reliable justification of the choice as well as omission of certain factors at study of the robustness of HPLC/UPLC methods. The risk level of factors is determined using a sp...

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Bibliographic Details
Main Authors: N. A. Epshtein, V. L. Sevastianova, A. I. Koroleva
Format: Article
Language:Russian
Published: LLC Center of Pharmaceutical Analytics (LLC «CPHA») 2019-01-01
Series:Разработка и регистрация лекарственных средств
Subjects:
Online Access:https://www.pharmjournal.ru/jour/article/view/552