Abstract

Quantitative determination of a trace level of carcinogenic agentmethyl iodide in naratriptan hydrochloride byGCusingECDdetection

Author(s): Mahesh D. Kote, B.M.Rao, M.Lalitha Devi, Ch.Krishna Murthy, B.Sirisha

Asimple and a quantitative GCmethod for the determination of trace level of methyl iodide; a suspected carcinogen in naratriptan hydrochloride drug substance(API) has been developed and validated. Methyl iodide being toxic, it is very important to control the level of the same in the final API. The GC column used wasAT-WAX, 30m0.53mm, 1.0mfilmthickness and the instrument employed for the method development and validationwasAgilent6890NGCequippedwith electron capture detector(ECD). In the developedmethod the limit of detection(LOD) ofmethyl iodide was about 0.25ppm and the limit of quantification was about 0.8ppm(LOQ). The method was validated with respect to precision, linearity and accuracy. The developed method can be very well employed and can be used in the quality control laboratories to monitor and control the trace levels of methyl iodide in naratriptan hydrochlorideAPI.