STABILITY SIGNALLING THE DEVELOPMENT AND VALIDATION OF ANALYTICAL METHODS FOR THE HPLC-BASED DETERMINATION OF RELATED COMPOUNDS IN THE PERAPANEL

DOI: https://doie.org/10.0721/Jbse.2024816257

Mr. A. VENKATESWARARAO , Dr. K. MANGAMMA , P. LOKA CHANDRUDU

Keywords:

HPLC, Perampanel and Robustness

Abstract:

The goal of the presented work is to develop and validate the chromatographic methods for determination of process as well as degradation related impurities in API’s. It also provides the valuable information about the product stability. In research work the forced degradation or stress testing is undertaken to demonstrate specificity when developing stability-indicating methods. These studies also provide information about the degradation pathways and degradation products that could form during storage. Forced degradation studies may help facilitate pharmaceutical development as well in areas such as formulation development, manufacturing, and packaging, better understanding of the potential liabilities of the drug molecule chemistry, and the resolution of stability related problems. The method was found to be simple, economical, suitable, precise, accurate& robust method for Quantitatively analysis of perampanel and its impurities and study of its stability.

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