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Development and validation of GC method for the determination of piperazine, 1-methyl piperazine and 1-ethyl piperazine in pharmaceutical drug substances

Shiva Raj, K.Siva Kumari, B.Vijaya Bhaskar

A simple GC method was developed for the quantitative determination of piperazine, 1-methyl piperazine and 1-ethyl piperazine in pharmaceutical drug substances like vardinafil and sildenafil. The GC method was developed to separate piperazine, 1-methyl piperazine and 1-ethyl piperazine. The separation was achieved on a DB-17, 30 m, 0.53 mm and 1m film thickness. The carrier gas used was Helium at a flow of 2 mL/min. The injector temperature and detector temperatureswere set at 250°C and 260°C respectively. The injection volumewas 1.0 L.Methanolwas used as diluent. The oven temperature was programmed at 150°C for 10 min, followed by 35°C /min up to 260°C for 2 minuets. The developed method was validated with respect to linearity, accuracy, precision, specificity, ruggedness and robustness.