Concentration and Solution Dependent Stability of Cloxacillin Intravenous Solutions

ABSTRACT The stability of cloxacillin at 5, 10, 20, 40, and 50 mg/mL in 5% dextrose in water (D5W) and normal saline (NS) solutions, stored at 4°C and 23°C was tested over an 18-day period. In addition to visual inspection and pH, the concentration of cloxacillin was determined by a stability-indicating liquid chromatographic method. Within and between days analytical error averaged less than 3%. The osmolarity of cloxacillin concentrations ranging from 0 mg/mL to 50 mg/mL in 3 different diluents, NS, D5W, and sterile water (SW), was also tested. The osmolarity of solutions in SW was low (204 mOsm for the 50 mg/mL) while the osmolarity of NS and D5W solutions ranged from 285 to 432 mOsm for all concentrations between 5 and 50 mg/mL. Therefore, stability studies were conducted only on NS and D5W solutions. At room temperature, all NS solutions retained more than 90% of their initial concentration for only 24 hours, whereas all D5W solutions, other than the 50 mg/mL solution, were more stable retaining 90% of the initial concentration for 4 days at room temperature. The 50 mg/mL solution developed a precipitate on the fourth day. After 18 days at room temperature, D5W solutions had between 20.27% remaining (50 mg/mL solution) and 4 7.9% (5 mg/mL solution), whereas the cloxacillin concentrations of NS solutions ranged from 21.5% (50 mg/mL) to 38.5% (5 mg/mL) remaining. Under refrigeration, D5W and NS solutions both retained more than 90% of the initial concentration for 18 days. In conclusion, we recommend that cloxacillin solutions be stored for 7 days at 4°C and then allowed to stand for no more than 24 hours at room temperature. Based on the faster rate of degradation observed at room temperature for NS solutions, D5W is the preferred diluent. RESUME La stabilite de la cloxacilline a 5, 10, 20, 40 et 50 mg/mL dans des solutions de dextrose a 5 % dans l'eau (D5W) et de solute physiologique normal (NS), entreposees a 4 °C et a 23 °C, a ete testee sur une periode de 18 jours. Outre les inspections visuelles el a la verification du pH, on a determine la concentration des solutions en cloxacilline, au moyen d'une epreuve de stabilite par chromatographie liquide. La marge d'erreur analytique pour une meme journee ou entre deux journees, determinee par une analyse d'echantillon repete, etait inferieure a 3 % en moyenne. L'osmolarite des concentrations de cloxacilline qui variaient entre 0 mg/mL et 50 mg/mL dans trois diluants differents, soit le NS, le D5W et l'eau sterile (SW), a aussi ete mesuree. L'osmolarite des solutions de SW etait faible (104 mOsm pour les concentrations de 50 mg/mL), comparativement a celle des solutions de NS et de D5W qui variait de 285 a 432 mOsm pour toutes les concentrations entre 5 et 50 mg/mL. Par consequent, les etudes de stabilite n'ont ete menees que pour les solutions NS et de D5W. A la temperature ambiante, toutes les solutions de NS ont conserve plus de 90 % de leur concentration initiale de cloxacilline pendant seulement 24 heures, contrairement aux solutions de D5W, sauf les solutions a 50 mg/mL, qui etaient plus stables et qui ont conserve 90 % de leur concentration initiale en cloxacilline durant 4 jours, a la temperature ambiante. Un precipite s'est forme dans la solution ci 50 mg/ mL, au quatrieme jour. Apres avoir ete entreposees pendant 18 jours a la temperature ambiante, les solutions de D5W avaient conserve 20,27 % (solution de 50 mg/mL) et 47,9 % (solution De 5 mg/mL) respectivement de leurs concentrations en cloxacilline, alors que les solutions de NS n'en avaient conserve qu'entre 21,5 % (50 mg/mL) et 38,5 % (5 mg/mL), respectivement. Refrigerees, les solutions de D5W et de NS ont toutes deux conserve plus de 90 % de leurs concentrations initiales en cloxacilline pendant 18 jours. En conclusion, nous recommandons d'entreposer les solutions de cloxacilline pendant 7 jours, a une temperature De 4 °C et de ne pas les laisser a la temperature ambiante pendant plus de 24 heures. Etant donne la vitesse de degradation plus grande des solutions de NS a temperature ambiante, que nous avons pu observer, le D5W represente le diluant de choix.

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