ISSN:
1573-904X
Keywords:
platinum
;
high-performance liquid chromatography (HPLC)
;
cisplatin analogue
;
D19466
;
lobaplatin
;
1,2-diaminomethyl-cyclobutane-platinum(II)-lactate
;
drug stability
;
shelf life
Source:
Springer Online Journal Archives 1860-2000
Topics:
Chemistry and Pharmacology
Notes:
Abstract The chemical stability of the new anticancer platinum analogue 1,2-diaminomethyl-cyclobutane-platinum(II)-lactate (D19466) in infusion media was studied in an accelerated stability testing experiment with a selective HPLC-UV method. Variables were time, temperature, light, concentration, and infusion mixture. Mean reaction rate constants of decomposition were, respectively, 0.9555 *10−2, 2.127 *10−2, and 4.221 *10−2 hr−1 at 37, 56, and 66°C at a concentration of 200 mg/L in normal saline. From the Arrhenius equation, shelf lives (5% loss) at 4, 22, 37, and 121°C were, respectively, calculated to be 41.6, 13.2, 5.7, and 0.15 hr. Mean reaction rate constant in 5% dextrose was 3.106 * 10−2 hr−1 (200 mg/L; 56°C) and differed from that in normal saline (P 〈 0.005). Mean reaction rate constant in Ringer lactate was 2.084 *10−2 hr−1 (200 mg/L; 56°C) (P 〉 0.05). There was no influence of normal daylight on the rate of decomposition. It is recommended to prepare D19466 infusions in normal saline. Chemical stability is then maximal 12 hr at room temperature or 24 hr at 4°C. No protection against normal daylight is required. Sterilization by heat is not possible.
Type of Medium:
Electronic Resource
URL:
http://dx.doi.org/10.1023/A:1015815908347
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