Stability of cefazolin sodium in various artificial tear solutions and aqueous vehicles.
The stability of cefazolin sodium reconstituted in four artificial tear solutions, two acetate buffer solutions, phosphate buffer solution, and 0.9% sodium chloride injection was studied. Cefazolin was reconstituted in Tearisol, Isopto Tears, Liquifilm Forte, and Liquifilm Tears; acetate buffer solution at pH 4.5 and pH 5.7; phosphate buffer solution at pH 7.5; and 0.9% sodium chloride injection. The solutions were stored at 4 degrees C, 25 degrees C, and 35 degrees C for seven days. All of the solutions were inspected for particulates, turbidity, color, and odor. Five assay determinations on each of three samples of each formulation were performed using a stability-indicating high-performance liquid chromatographic assay. Cefazolin stability was influenced primarily by pH and storage temperature. Reconstitution of cefazolin sodium in the alkaline tear solutions Isopto Tears and Tearisol and in phosphate buffer solution resulted in particulate and color formation at 25 degrees C and 35 degrees C. Turbidity was noted after cefazolin sodium was reconstituted in Isopto Tears. No color or precipitate formation was evident after seven days at 25 degrees C and 35 degrees C in the formulations of acidic pH containing Liquifilm Tears, Liquifilm Forte, 0.9% sodium chloride injection or acetate buffer solution as the vehicles. The extent of degradation of cefazolin was substantially higher in the formulations of alkaline pH than in those of acidic pH at 35 degrees C and 25 degrees C. All of the formulations retained more than 90% of their initial concentration when stored at 4 degrees C. Cefazolin sodium, when reconstituted in artificial tear solutions with an acidic pH, is stable for up to three days at room temperature.
Pfizer Central Research, Groton, CT 06340.
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D002437:Cefazolin; D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D006863:Hydrogen-Ion Concentration; D009883:Ophthalmic Solutions; D013666:Tears; D013696:Temperature; D013997:Time Factors
D009883:Ophthalmic Solutions; D002437:Cefazolin