Development and validation of analytical methods to control the quality and stability of hospital preparations

In hospital pharmacies, several pharmaceutical formulations are prepared on a relatively large scale. So, they can be considered as semi-industrial. However, they are not controlled like industrially prepared drugs because they are often quite specific and proper methods are lacking.

Another issue concerns the stability. Although for some of these products stability data can be found in literature, these are not always unequivocal or they concern preparations with different concentrations and/or different matrices so that the conclusions do not necessarily apply for the products studied here.

In this study, analytical methods will be developed and validated to control the quality and stability of hospital preparations. These methods should be preferably simple, fast and low cost. Liquid chromatography will be the preferred technique. Attention will be paid to antibiotic infusions with ceftazidime and piperacillin/tazobactam in portable pumps, as well as multi component drugs like a preservation solution containing lincomycin, polymyxin and vancomycin or a mixture of atropine, fentanyl and cisatracurium.