title: Chemical stability of cefotetan disodium in 5% dextrose and 0.9% sodium chloride injections.
abstract: The chemical stability of cefotetan disodium in 5% dextrose and 0.9% sodium chloride injections has been studied using a stability-indicating high-pressure liquid chromatographic (HPLC) assay method. The drug appears to be relatively unstable at 25 degrees C (expiry time 2 days), compared with at least 41 days at 5 degrees C and at least 60 days at -10 degrees C. Thawing the frozen samples in a microwave (90 s) did not cause any significant decomposition. The manufacturer's recommended expiry time of 4 days at 5 degrees C and at least 7 days at -10 degrees C is very conservative. The HPLC method developed is accurate and precise with a relative percentage standard deviation of 1.7 based on six readings. The method appears to be stability-indicating as the samples decomposed under drastic conditions had almost no drug left and new peaks were observed in the chromatograms.
authors.affiliation: Department of Pharmaceutics, University of Houston, TX 77030.
authors.forename: V
authors.initials: V
authors.lastname: Das Gupta
authors.forename: Y
authors.initials: Y
authors.lastname: Pramar
authors.forename: C
authors.initials: C
authors.lastname: Odom
authors.forename: T
authors.initials: T
authors.lastname: Zerai
authors.forename: C
authors.initials: C
authors.lastname: Bethea
mesh_terms: D015313:Cefotetan / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D007267:Injections; D013696:Temperature
chemical_list: D015313:Cefotetan