Stability of moxifloxacin injection in peritoneal dialysis solution bags (Dianeal PD1 1.36% and Dianeal PD1 3.86%).
OBJECTIVE
Moxifloxacin is a new fluorquinolone with broad-spectrum activity. It is suitable for treating peritonitis in peritoneal dialysis (PD) patients. The objective of this study was to test stability of moxifloxacin in PD solutions stored at different temperatures.


METHODS
Dialysis solution bags were used at two glucose concentrations; Dianeal PD1 1.36% and Dianeal PD1 3.86%. Moxifloxacin solution (2%) was injected into nine 2-L bags of Dianeal PD1 1.36% and nine bags of Dianeal PD1 3.86% under aseptic conditions to achieve a nominal concentration of 25 mg/L. Three bags of Dianeal PD1 1.36% and three bags of Dianeal PD1 3.86% were stored at each of three temperatures (4, 25 and 37 degrees C) and the same way for. Duplicate samples (2 mL) were taken at different times and precipitation, cloudiness, colour and pH was analysed. Moxifloxacin concentrations were measured using a modified HPLC method.


RESULTS
The mean moxifloxacin concentration in the Dianeal PD1 1.36% solution remained > or =90% of the initial concentration for 14 days at 4 degrees C, 7 days at 25 degrees C and 3 days at 37 degrees C. For Dianeal PD1 3.86% moxifloxacin concentrations remained > or =90% for 14 days at 4 degrees C, 3 days at 25 degrees C and 12 h at 37 degrees C.


CONCLUSIONS
Moxifloxacin shows sufficient stability in both PD bags for use in PD patients.
Fernández-Varón
E
E
Department of Pharmacology, Faculty of Medicine, University of Murcia, Murcia, Spain. emiliofv@um.es
Marín
P
P
Espuny
A
A
Villamayor
L
L
Escudero
E
E
Cárceles
C
C
D000890:Anti-Infective Agents / Q000737:chemistry*; D001372:Aza Compounds / Q000032:analysis / Q000737:chemistry*; D002851:Chromatography, High Pressure Liquid; D015314:Dialysis Solutions; D004355:Drug Stability; D024841:Fluoroquinolones; D007267:Injections; D000077266:Moxifloxacin; D010530:Peritoneal Dialysis; D011804:Quinolines / Q000032:analysis / Q000737:chemistry*; D013696:Temperature
D000890:Anti-Infective Agents; D001372:Aza Compounds; D015314:Dialysis Solutions; D024841:Fluoroquinolones; D011804:Quinolines; D000077266:Moxifloxacin