Abstract

LIQUID CHROMATOGRAPH MASS SPECTROMETRIC METHOD FOR DETERMINATION OF N-NITROSO-VARENICLINE (NNV) IN VARENICLINE

Rohan More*, Amit Gosar, Tabrez Shaikh, Ravi Patole, Fenil Savla and Aarti Mundhe

ABSTRACT

A simple, sensitive, specific, linear, accurate, robust, and effective liquid chromatography mass spectrometry method has been developed and validated for the determination of the N-nitroso-Varenicline (NNV) in Varenicline Tablets. NNV impurity is a possible NDSRI impurity that may be present in Varenicline. The method is validated as per International Council for Harmonisation (ICH) guidelines, for which the limits of detection and quantitation obtained were 0.13 ppm and 0.66 ppm, respectively. The precision is established for NNV with a %RSD of 1.33. The correlation coefficient found for the linearity study was 0.9997, and the percentage recovery of the spiked impurity in the drug substance obtained was in the range of 98.92 to 118.78 for a 30% to 200% level, ensuring the accuracy of the method. The method can be adapted to determine the nitrosoamine (NNV) content in Varenicline Tablets.

Keywords: Liquid chromatography with Mass spectrometer (LCMS), Varenicline Tablets, NNV, SCIEX, validation, N-Nitroso Varenicline.