Stability of cefotaxime sodium after reconstitution in 0.9% sodium chloride injection and storage in polypropylene syringes for pediatric use

Abstract

A stability-indicating high-performance liquid chromatographic assay method was used to study the stability of cefotaxime sodium (50 mg/mL) in 0.9% sodium chloride injection in polypropylene syringes at 5 deg C and 25 deg C. The concentrations of the drug were directly related to peak heights, and the percent relative standard deviation based on 5 injections was 1.1. There were at least three products of decomposition that separated from the intact drug. At 5 deg C, the decomposition was less than 3% when stored for 18 days, and at 25 deg C, the loss in potency was less than 10% after 1 day of storage. When stored for 18 days at 5 deg C, the pH value of the injection decreased from 5.3 to 5.0 when stored at 25 deg C for 1 day. The drug was not absorbed onto the syringes, and the intensity of the light yellow color did not change significantly during storage at 5 deg C but increased during storage at 25 deg C.