Cefotaxime sodium for injection reconstitution stability study in intravenous and intramuscular diluents

Cefotaxime is a third-generation parenteral cephalosporin antibacterial used in the treatment of infections due to susceptible Gram-positive and Gram-negative bacteria. Cefotaxime is given as the sodium salt by deep intramuscular injection or intravenously by slow injection over 3 to 5 minutes or by infusion over 20 to 60 minutes. Reconstitution stability of Cefotaxime sodium in different intravenous diluents such as sterile water for injection, 0.9% Sodium chloride solution, 10% Dextrose, 5% Dextrose + 0.9% sodium chloride solution, Lactated ringers injection, 8.5% TRAVASOL (amino acid) injection without electrolytes and 10% invert sugar injection were studied at below 25°C for 24 hours and at 2-8°C for 5 days. Reconstitution stability studies also performed with Metronidazole infusion (500mg/ml) for 24 hours at refrigerated condition; sterile water for injection as intravenous injection (180mg/ml) and intramuscular injection (330 mg/ml) and 1% Lignocaine as intramuscular (330 mg/ml) injection for 12 hours at below 25°C, 5 days at 2-8°C with plastic syringes and 7 days at 2-8°C in its original container. The samples were observed physically and analysed for Cefotaxime Sodium content (assay) and its related substances by stability indicating HPLC method. The results showed that, no abnormal color was developed in all the reconstituted solutions during the study period and the pH values were between 3.59 to 6.25. Also, Cefotaxime Sodium contents were not less than 90% and individual impurities and total impurities were not more than 6% and 10% respectively. It has been concluded that Cefotaxime Sodium for injections are stable for 12 hours at below 25°C, for 5 days in plastic syringes at 2-8°C and for 7 days in original container at 2-8°C after reconstitution with intramuscular diluents.Reconstitution stability in the used intravenous diluents are 24 hours at below 25°C and 5 days at 2-8°C.

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

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