Reconstitution Stability of Ceftriaxone Sodium for Injection in Intravenous Diluents

The objective of this study to evaluate reconstitution stability of Ceftriaxone in different diluents like sterile water for injection, 0.9% Sodium chloride solution, 10% Dextrose, 5% Dextrose + 0.9% NaCl solution, Sodium lactate over 3 days at room temperature and 10 days at refrigerated condition (2-8°C), and 10% invert sugar, 5% Sodium bicarbonate, Freamine III, 10% Mannitol over 24 hrs at room temperature, and Ceftriaxone admixture solution with Metronidazole HCl injection along with the diluents in 0.9% NaCl and 5% Dextrose over 24 hrs at room temperature. No data are available, however, about the Ceftriaxone stability at various temperatures in Freamine III, Metronidazole HCl injection, sodium lactate, 5% Sodium bi carbonate, 10% invert sugar and 10% Mannitol. Ceftriaxone was reconstituted with 19.2 mL of sterile water for injection and then injected to the bags of above mentioned diluents and stored the solutions at room temperature and refrigerator as specified above. The samples of Ceftriaxone solutions in sterile water for injection, 0.9% Sodium chloride solution, 10% Dextrose, 5% Dextrose + 0.9% NaCl solution, Sodium lactate were collected after 3 days at room temperature and 10 days at refrigerated stored, and the solutions in 10% invert sugar, 5% Sodium bicarbonate, Freamine III, 10% Mannitol were collected after 24 hrs at room temperature. The Ceftriaxone solutions in 0.9% NaCl and 5%Dextrose solutions admixed further with Metronidazole HCl injection (7.5 mg/mL). All these samples were tested with a specific stability indicating methods for the estimation of content of Ceftriaxone and Ceftriaxone impurities. A clinically significant loss of potency was defined as a greater than ten percent decrease from its initial concentration. The concentration of Ceftriaxone was 90% or more for 3 days at room temperature, 10 days at 2-8º C and 24 hrs at room temperature. Thus, Ceftriaxone can be stored in the solution having the concentration of 40mg/mL with Sterile water for Injection, 0.9% NaCl solution, 10% Dextrose Solution, 5% Dextrose + 0.9% NaCl solution are stable up to 3 days period at room temperature and 10 days if stored at refrigerated conditions, and concentration of 40mg/mL with Sodium Lactate, 10% Invert Sugar, 5% Sodium bi Carbonate, Freamine III, 10% Mannitol are stable up to 24 hrs at room temperature, and concentration of 10mg/mL with an admixture of Metronidazole HCl (concentration of 7.5mg/mL) + 0.9% NaCl solution and Metronidazole HCL (concentration of 7.5mg/mL) + 5% Dextrose in water are stable up to 24 hrs at room temperature.

Author(s): Durga Mallikarjuna Rao Tippa and Dr. N. Singh

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