Development and Validation of an Analytical Method for Identification of Granulated Nicarbazin by near Infrared Reflectance Spectroscopy

Abstract

A rapid method was developed for verification of the identity of granulated nicarbazin raw material by near infrared reflectance. A library was developed from 30 second derivative near infrared reflectance spectra obtained from 15 representative batches of nicarbazin. Following identification, new batches were qualified by conformance testing according to the wavelength distance method. The identification/qualification method was validated for selectivity and for ruggedness utilising statistically designed experiments.

Keywords

Pharmaceutical analysis near infrared spectroscopy method validation nicarbazin conformity index conformance testing wavelength distance method statistical design of experiments

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