Stability and compatibility studies of cephamandole nafate with PVC infusion bags.
A rapid isocratic technique was developed for the analysis of cephamandole nafate and cephamandole in parenteral solutions using high-performance liquid chromatography (HPLC) with UV detection and C18 column. The availability and compatibility of drugs from solutions infused via plastic infusion bags through plastic administration sets have been examined. No significant drugs loss was observed during simulated infusions (n = 4) for 1 h using PVC infusion bags and administration sets. No significant difference was found between infusion solutions (5% glucose or 0.9% NaCl). The stability of drugs was also studied in solution in PVC bags after storage at room temperature and at 4 degrees C without protection from light. The results show the stability of cephamandole nafate during 24 h at room temperature and 7 days storage at 4 degrees C to be satisfactory, irrespective of the infusion solution (5% glucose or 0.9% NaCl). However, an almost immediate and total transformation of cephamandole nafate to cephamandole in 5% glucose has been observed, whereas in 0.9% NaCl both forms were found in similar proportions.
Faouzi
M A
MA
Laboratoire de Pharmacologie, Pharmacocinétique et Pharmacie Clinique, Faculté des Sciences, Pharmaceutiques et Biologiques, Lille, France.
Dine
T
T
Luyckx
M
M
Goudaliez
F
F
Mallevais
M L
ML
Gressier
B
B
Brunet
C
C
Cazin
M
M
Cazin
J C
JC
D002138:Calibration; D002435:Cefamandole / Q000031:analogs & derivatives* / Q000737:chemistry; D002851:Chromatography, High Pressure Liquid; D004349:Drug Packaging; D004355:Drug Stability; D004356:Drug Storage; D006801:Humans; D006868:Hydrolysis; D007263:Infusions, Parenteral / Q000295:instrumentation; D008027:Light; D011143:Polyvinyl Chloride / Q000737:chemistry*; D015203:Reproducibility of Results; D013056:Spectrophotometry, Ultraviolet; D013696:Temperature
D002435:Cefamandole; C012810:cefamandole nafate; D011143:Polyvinyl Chloride