Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING ASSAY METHOD FOR RIVAROXABAN DRUG BY HPLC

Zareen N. Sayeda* and Tabssum Hangad

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Abstract

For small compounds, the forced degradation research is a critical analytical component of the drug development process. Stress testing is a method of demonstrating specificity in order to develop a stabilityindicating analytical method using HPLC, i.e. an analytical method capable of separating degradant peaks from drug substance/drug product peaks. Stability studies are required to propose the shelf life of new drug ingredients and/or drug products according to ICH recommendations (Q1A). To estimate the shelf life of a drug substance or drug product, three types of stability tests must be completed: accelerated stability (ACC), intermediate stability (INS), and regulated room temperature (CRT) stability. The intrinsic stability of the molecule is determined by a stability analysis, and it is expected that the drug ingredient will decompose and form additional molecules known as contaminants. Various stress conditions are used in forced degradation research to degrade/decompose the main component and generate impurities, which should separate from the main compound and each other. As a result, forced degradation studies are used to estimate the degradant/decomposed impurities that occur during stability tests and to suggest the shelf life of new drug ingredients and/or drug products.

Keywords: HPLC, Stress conditions, Stability, Analytical method, Validation.