Abstract

INVITRO ANALYTICAL EVALUATION OF NITROSAMINE- A CARCINOGENIC IMPURITIES IN SARTANS BY GC MS/MS METHOD

KK Kalyan Kumar*, Rakesh Kumar and M. Venkata Reddy

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Abstract

N - Nitrosamine dimethyl amine (NDMA) and N Nitrosamine diethyl amine (NDEA) are the carcinogenic impurities detected in the sartan group of drugs in 2018 by FDA in the marketed formulations. A standard solution of NDMA and NDEA are solubilised in an aprotic solvent like DMS and the sample solutions are prepared from the marketed formulations of the reputed pharmaceutical company and were injected with a concentration of 0.004 and 4 ppm for NDMA and NDEA respectively to the GC with a programmed temperature controller using Elite Wax (30 m x 0.25 mm x 0.5 μm) column, helium as carrier gas and hyphenated to the Mass Spectrometer powered with Quadrupole mass analyser and photomultiplier tube detector. The retention and m/z can be found in 5.632,6.514 and 74.0 and 102.0 for NDMA and NDEA respectively. The method for these impurities can be validated as per the ICH Q2 R1 to its system suitability, specificity, Precision, accuracy, LOD and LOQ.

Keywords: NDMA, NDEA, Carcinogenic Impurities, GC MS, Validation, Olmesartan Medoxomil.