An-Najah Staff

The purpose of this study is to evaluate the stability of (60 mg/ml)  Cefotetan disodium (CTT) in 0.9% sodium chloride sterile saline solution  stored in polypropylene syringes at ambient temperature (25 ± 1°C) and 5 ±  1°C by the use of a stability indicating high performance liquid  chromatographic assay method. Methods: Solutions of CTT (60 mg/ml)  were prepared from commercially available 1 g lyophilized vials in normal  saline. They were filled into 5-ml polypropylene syringes and stored at  ambient and 5°C temperatures. The strengths of CTT were determined by  high performance liquid chromatographic assay after 0, 1, 2, 3, 6, 12, 18, 24  and 30 days. The concentrations of the drug were directly related to the peak  area, and the percent relative standard deviation based on 5 concentrations  was 0.9. The initial and final pH values were recorded and compared, also  the initial and final color of the solution were compared. Results: There was  at least one decomposition product which was separated from the parent  drug. The loss in potency was less than 9% after 6 days of storage at  ambient temperature, while the loss of potency at 5°C was less than 2%. The  pH value increased from 5.7 to 6 when the injection was stored at 5 °C for  30 days. The drug was not adsorbed onto the plastic syringes. The intensity  of the light yellow color was increased during the storage period at ambient  temperature but didn’t change significantly with storage at 5 °C.  Conclusion: Cefotetan 60 mg /ml in normal saline solution stored in  polypropylene syringes was stable for 6 days at 25 °C and for 24 days when  stored at 5 °C.