Method Validation and Quantitative Determination of 2–Mercapto Benzimidazole in Lansoprazole by Lc/Ms/Ms

Noor Shabana; K.Dayananda Reddy

Volume : IV, Issue : III, March - 2015

Method Validation and Quantitative Determination of 2–Mercapto Benzimidazole in Lansoprazole by Lc/Ms/Ms

Noor Shabana, K. Dayananda Reddy

Abstract :

A sensitive and selective liquid chromatographic–tandem mass spectrometric (LC/MS/MS) method was developed and validated for the trace analysis (>1 ppm level) of 2–Mercapto benzimidazole, a genotoxic impurity, in lansoprazole drug. The chromatographic separation was achieved on Hypersil BDS C8 (50 x 3 mm, 3 �m) column using a mobile phase consisting of 5mM ammoniumacetate, methanol and acetonitrile (60:20:20, v/v/v) at flow rate of 0.5 mL/min. The API–4000 LC/MS/MS was operated on an electrospray ionization equipped with an ESI interface operated in positive mode. The multiple–reaction monitoring (MRM) mode was used during the analytical run and it is able to quantitate up to 0.1ppm of 2–Mercapto benzimidazole. The newly developed method was validated as per achieved on International Conference on Harmonization (ICH) guidelines