Stability of oxaliplatin in infusion bags containing 5% dextrose injection

被引:10
|
作者
Andre, Pascal
Cisternino, Salvatore
Roy, Anne-Lise
Chiadmi, Fouad
Schlatter, Joel
Agranat, Pascal
Fain, Olivier
Fontan, Jean-Eudes
机构
[1] Univ Hosp Jean Verdier, Dept Pharm Toxicol, F-93143 Bondy, France
[2] Univ Paris 06, Organ Chem Lab, Paris, France
关键词
antineoplastic agents; color concentration; containers; contamination; dextrose; diluents; hydrogen ion concentration; injections; oxaliplatin; photodecomposition; polyolefin; precipitation; stability; storage; temperature;
D O I
10.2146/ajhp060369
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Purpose. The stability of oxaliplatin in infusion bags containing 5% dextrose injection was studied. Methods. Solutions of oxaliplatin 0.7 mg/mL were prepared in polyolefin infusion bags containing 5% dextrose injection and stored at 3-7 degrees C in a lightproof bag, at 20-24 degrees C with continuous exposure to artificial light, and at 20-24 degrees C with continuous exposure to fluorescent light in a lightproof bag. Samples were analyzed at 1, 2, 3, 4, 5, 7, 14, and 30 days and assayed in duplicate. Stability was measured using a stability-indicating high-performance liquid chromatographic method. Samples were also examined for changes in color and pH and for the presence of particulate matter. Results. All samples retained over 90% of their initial concentration over the study period. No color changes or visible precipitation was observed, and the pH of all samples remained stable. Neither temperature nor artificial light had any significant effect on the stability of oxaliplatin. Conclusion. Oxaliplatin 0.7 mg/mL in infusion bags containing 5% dextrose injection was chemically stable for at least 30 days at both 3-7 degrees C and 20-24 degrees C without regard to light exposure.
引用
收藏
页码:1950 / 1954
页数:5
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