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Abstract

DEVELOPMENT AND VALIDATION OF A REFRACTOMETRIC ASSAY METHOD

K. C. Ajithkumar and K. Pramod*

ABSTRACT

Refractometry is used to detect the refractive index of chemical substances, when light passes through it. Since every chemical substance or sample has specific refractive index at specific concentration, here we used it as an assay method and validated the method in terms of linearity and range, accuracy and precision. The detection of limit and the quantitation of limit were determined as per ICH guidelines. The method is expected to be extended in quantification of variety of samples.

Keywords: ICH, linearity, refractive index, range, precision, detection limit, quantitation limit


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