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Dr. Sachin Sonavane*, Vishal Solse and Samadhan Kadam


Objective: Detection and control of Nitrosodiethylamine (NDEA) in phase transfer catalyst i.e Triethyl benzyl ammonium chloride. Hydrochloride salt of benzyltriethylammonium which acts as a phase-transfer catalyst in chemical reactions. Phase-transfer catalyst is a catalyst that facilitates the migration of a reactant from one phase into another phase where reaction occurs. Tri ethyl benzyl ammonium chloride catalyst is easily available and inexpensive which is used in many API molecules. Nitrosoamine is an organic compound containing the group –NNO attached to two organic groups. Nitrosoamines are formed by reaction of secondary or tertiary amines with a nitrosating agent. Some of the nitrosoamines are classified as probable human carcinogens. A sensitive High performance liquid chromatography (HPLC) method was developed and validated for the determination of Nitrosodiethylamine in Triethyl benzyl ammonium chloride. HPLC column Kanak PH-HEX, wavelength 250 mm, internal diameter 4.6mm, particle size 5μm with ultra violet detector (UV) was used. The proposed method is specific, linear, accurate, rugged and precise. The calibration curve of Nitrosodiethylamine showed good linearity over the concentration range of 0.125 ppm to 3.75 ppm with respect to test solution concentration and the regression coefficient was 0.999 for analyte. Method had very low limit of detection (LOD) and limit of quantification (LOQ) of analyte which proves that the method is sensitive and suitable for quantification of Nitrosodiethylamine impurities at trace level.

Keywords: Triethyl benzyl ammonium chloride (TEBAC); NDEA; method development and validation.

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