Chemical stability of the antitumor drug mitomycin C in solutions for intravesical instillation.
The chemical stability of the antitumor drug mitomycin C has been investigated by using a stability indicating high performance liquid chromatographic assay. The stability tests were performed in different media and under different conditions which are important for the clinical urology practice in the intravesical chemotherapeutic treatment of superficial bladder cancer. It is concluded that mitomycin C can be dissolved in Water for Injection to a concentration of 30 or 40 mg/50 mL. These solutions are stable for four days at ambient temperature and in the dark. Storage of solutions with a concentration of 30 mg/50 mL are stable for four days in the refrigerator but higher concentrations show precipitation after one day storage at 4 degrees C. Dissolution and storage in 0.9% sodium chloride solution or phosphate buffer pH 7.4 is not recommended because in these, media degradation and/or precipitation occur.
Beijnen
J H
JH
Slotervaart Hospital/Netherlands Cancer Institute, Amsterdam.
van Gijn
R
R
Underberg
W J
WJ
D000283:Administration, Intravesical; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000737:chemistry*; D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D006863:Hydrogen-Ion Concentration; D016685:Mitomycin; D008937:Mitomycins / Q000008:administration & dosage / Q000737:chemistry*; D012996:Solutions
D000970:Antineoplastic Agents; D008937:Mitomycins; D012996:Solutions; D016685:Mitomycin