QUANTITATION OF CEFEPIME-CENTER-DOT-2HCL DIHYDRATE IN CEFEPIME-CENTER-DOT-2HCL MONOHYDRATE BY DIFFUSE-REFLECTANCE IR AND POWDER X-RAY-DIFFRACTION TECHNIQUES

The identification, characterization and quantitation of crystal forms is becoming increasingly important within the pharmaceutical industry . Multi-disciplinary, physical analytical techniques are necessary for this task. In this work, diffuse reflectance mid-infrared (IR) and po wder X-ray diffraction (XRD) analyses were used to identify two differ ent hydrated forms of cefepime . 2HCl, a cephalosporin. Characterizati on of the mono- and dihydrate forms led to separate IR and XRD quantit ative assays for the determination of dihydrate content in cefepime . 2HCl monohydrate bulk material. For the IR assay, a working range of 1 .0-8% (w/w) was established with a minimum quantifiable level (MQL) of 1.0% (w/w) and a limit of detection (LD) of 0.3% (w/w) dihydrate in m onohydrate material. The XRD assay displayed a working range of 2.5-15 % (w/w) with an MQL of 2.5% (w/w) and an LD of 0.75% (w/w). Cross vali dation was performed between the two techniques, with a good correlati on displayed for each assay as compared with the known concentrations and as compared with each other. In addition, a full evaluation of pot ential assay errors was made.