1Department of Analytical Research and Development, Reddy's Laboratories Ltd., Visakhapatnam, 530045, Andhra Pradesh, India
2Department of Inorganic and Analytical Chemistry, Andhra University, Visakhapatnam, 530003, Andhra Pradesh, India
This study describes the development and quantification of reverse phase HPLC method for the genotoxic impurity i.e. 2- (dimethyl amino) thioacetamide commonly named as DIS. It is one of the key raw material for the synthesis of Nizatidine product. There is no method is available for the determination of DIS in any active pharmaceutical ingredients/drug substance. After several development trials, DIS quantification at extremely low level was accomplished on YMC PACK ODS A, 15cm x 4.6mm, 3.0μm column using the combination of sodium acetate and n-Heptane sulfonic acid sodium salt with additives of Acetic acid and Tri ethyl amine as buffer and acetonitrile as organic modifier. Diluent was selected as water. The flow was selected as 1.5mL/min and temperature of column was maintained at 35°C. The wavelength was selected at 254nm and injection volume was 10μL. The limit of detection and limit of quantification were 20ppm and 50ppm respectively. The method was validated and found to be precise, accurate and robust. The method can be used for determination of 2- (Dimethyl amino) thioacetamide, which is the key starting material for preparation of Nizatidine.
2-(Dimethyl amino) thioacetamide, RP-HPLC, UV Detector and Nizatidine
