Abstract
DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD TO SEPARATE LOW LEVELS OF ATOLTIVIMAB, MAFTIVIMAB AND ODESIVIMAB AND OTHER RELATED COMPOUNDS

Meher Unnisa, Imam Pasha Syed*, Mubeena Shereen, Ruqsar Fatima and Anupama Koneru

ABSTRACT

A method for estimation of drug components of InmazebTM injection using RP-HPLC method is reported in this article. Quantitative estimation of Atoltivimab (ATO), Maftivimab (MAF), and Odesivimab (ODE) and validation of the proposed method as per the ICH guidelines is reported in this article. Forced degradation studies were carried out to study the interference of degradation products in the estimation of drug components and are found to be within regulated limits.

Keywords: Atoltivimab, Maftivimab, Odesivimab, ICH guidelines, Quantification.


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