European Journal of Biomedical and Pharmaceutical Sciences

IDENTIFICATION AND IMPURITY PROFILING OF PROCESS RELATED IMPURITIES IN DTPEE

Shwetali K. Churi and Manohar V. Lokhande*

ABSTRACT

DTPEE, an antipsychotic drug, has been accepted for the treatment of schizophrenia as well as for the treatment of acute manic episodes associated with bipolar I disorder as either monotherapy or adjunct therapy to lithium or divalproex.1-7It is advertised underneath the brand name of Seroquel, chemically known as 2-[2-(four-dibenzo[b,f][1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]ethanol fumarate (2:1) (DTPEE). Its empirical system is[ (C21H25N3O2S)2·C4H4O4 ]and Molecular wt. is 883.11. DTPEE being one of the top 15 bestselling drug, there is always a possibility of low first-rate standard version because of cost pressure. hence, the improvement of an accurate and green stability indicating analytical technique to decide the fine of the product is a vital activity throughout the technique improvement of the product in widespread pharmaceutical enterprise as procedure is both progressed continuously with the use of recent reagents; intermediates, etc., or route of synthesis itself adjustments a while. The parameters such as LOD, LOQ, Accuracy and HPLC were analyzed.

Keywords: Accuracy, LOD, LOQ, Precession and HPLC Techniques.