Chemical stability of cefotetan disodium in 0.9 % sodium chloride sterile saline solutions and storage in polypropylene syringe

Abstract EN

Purpose : 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.