Use of hyphenated LC-MS/MS technique for characterization of impurity profile of quetiapine during drug development.

As a part of an integrated quality concept in drug development, the multidimensional evaluation of impurity profiles by LC-MS/MS is presented for quetiapine--an active pharmaceutical ingredient (API). LC-UV is commonly employed for the determination of impurities and degradation products. In this work LCMS/MS technique is proposed as a modern alternative for the characterization of these compounds. The use of this technique allowed to develop methods for the separation and identification of the impurities resulting from both, synthesis and degradation processes.