The physical and chemical stability of cisplatin (Teva) in concentrate and diluted in sodium chloride 0.9%

Autor: Edmund Grześkowiak, Emilia Mierzwa, Aleksandra Głęboka, Agnieszka Karbownik, Hanna Urjasz, Edyta Szałek
Rok vydání: 2012
Předmět:
Zdroj: Contemporary Oncology
ISSN: 1428-2526
DOI: 10.5114/wo.2012.31775
Popis: Aim of the study The subject of study was the stability of cisplatin in concentrate in glass vials and diluted in polyethylene (PE) bags stored at 15–25°C for up to 30 days. Material and methods Original vials of cisplatin injection (1 mg/ml, Teva) were stored at room temperature and subjected to re-piercing after 1, 2, 3, 7, 14, 21, 28 and 30 days following the initial piercing. Cisplatin infusions at nominal concentrations of 0.1 mg/ml were prepared in 0.9% sodium chloride (1000 ml) in PE bags. Chemical stability was measured by means of a stability-indicating high-performance liquid chromatography (HPLC) assay. Physical stability was assessed by visual inspection in normal light. Results The concentration of cisplatin at each sampling time in the analysed solutions remained within 92.0–100.7% of initial concentration, regardless of the container. No changes in colour or turbidity were observed in any of the vials or prepared solutions. Conclusions Cisplatin, both undiluted in glass containers and diluted with NaCl 0.9% in PE bags, remains stable (< 10% degradation) for at least 30 days at room temperature when protected from light.
Databáze: OpenAIRE