QUANTITATION OF CEFEPIME-CENTER-DOT-2HCL DIHYDRATE IN CEFEPIME-CENTER-DOT-2HCL MONOHYDRATE BY DIFFUSE-REFLECTANCE IR AND POWDER X-RAY-DIFFRACTION TECHNIQUES
De. Bugay et al., QUANTITATION OF CEFEPIME-CENTER-DOT-2HCL DIHYDRATE IN CEFEPIME-CENTER-DOT-2HCL MONOHYDRATE BY DIFFUSE-REFLECTANCE IR AND POWDER X-RAY-DIFFRACTION TECHNIQUES, Journal of pharmaceutical and biomedical analysis, 15(1), 1996, pp. 49-61
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.