Analytical Method Validation Of N-Nitroso Methoxyphenamine Impurity By Lc-Ms/Ms In Methoxyphenamine Hcl

Abstract

Sensitive LC-MS/MS techniques were developed and verified for N-Nitroso Methoxyphenamine impurity in the active pharmaceutical ingredient (API) of Methoxyphenamine HCl. Ultra Performance Liquid Chromatography hyphenated with triple Quadrupole LC-MS/MS Mass Spectrometer was employed in the method. Method development and validation procedures were carried out as per ICH guidelines. The developed method was found to be robust, accurate, linear, and specific. Over a predefined concentration range the calibration curves demonstrated satisfactory linearity; the correlation coefficient was 0.999. The limit of quantification (LOQ) and limit of detection (LOD) were 0.25 ppm and 0.083 ppm respectively. Analytical test method for determination of N-nitroso methoxyphenamine in methoxyphenamine hydrochloride by LC-MS/MS was validated for System Suitability, Specificity, Precision, Accuracy and Linearity