what is robustness test in analytical method validation (AMV)

Robustness

The robustness of an analytical procedure is a measure of its capacity to remain unaffected by small but deliberate variations in method parameters and provided an indication of its reliability during normal usage. Robustness is usually demonstrated by making small deliberate change to one of the operating parameters of the method, analysing sample and comparing the results to those obtained using the prescribed method. Robustness is the property of being strong and healthy in constitution. When it is transposed into a system, it refers to the ability of tolerating perturbations that might affect the system’s functional body. In the same line robustness can be defined as “the ability of a system to resist change without adapting its initial stable configuration. Robustness in the small refers to situations wherein perturbations are small in magnitude, which considers that the “small” magnitude hypothesis can be difficult to verify because “small” or “large” depends on the specific problem. Conversely, “Robustness in the large problem” refers to situations wherein no assumptions can be made about the magnitude of perturbations, which can either be small or large. It has been discussed that robustness has two dimensions: resistance and avoidance

Bhanu Pratap Singh

BHANU PRATAP SINGH IS EXPERIENCED IN PHARMACEUTICAL, AUTHOR AND FOUNDER OF PHARMACEUTICAL GUIDESLINE (WWW.PHARMAGUIDESLINE.COM), A WIDELY READ PHARMACEUTICAL BLOG SINCE 2019. EMAIL:- INFO@PHARMAGUIDESLINE.COM

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