Stability-indicating HPLC Method for Determination of 7,8,9,10- tetrahydroazepino[2,1b]quinazolin-12(6H)-one, a Potential Anticancer Agent

Abstract

7,8,9,10-Tetrahydroazepino[2,1b]quinazolin-12(6H)-one (TAZQ), a synthetic analogue of vasicine, has been reported as anticancer, bronchodilator, antiinflammatory, antitussive, antiarthritic and antiasthamatic compound. This drug candidate is presently in pre-clinical studies for anticancer activity. The development of a validated reverse phase-HPLC (RP-HPLC) method is herein reported for its analysis and stability assessment. The analytical method was optimized using a C-18 column (at ambient temperature) and methanol:water (80:20 v/v) as mobile phase at flow rate of 0.9 ml/min. The eluents were monitored at 254 nm. The retention time of 7,8,9,10-Tetrahydroazepino[2,1b]quinazolin-12(6H)-one was observed to be 3.9 min. It degraded significantly under alkaline conditions whereas negligible degradation was observed under acidic, oxidative, thermal and photolytic stress conditions. The peak of major degradation product, resulting from alkaline degradation, was well resolved from the peak of 7,8,9,10-Tetrahydroazepino[2,1b]quinazolin-12(6H)-one. This method has been found to be linear, accurate, precise, robust, sensitive, specific, suitable and stability indicating.