Application of the kinetic turbidimetric limulus test to ceftazidime injection / 中国药理学通报

ABSTRACT

AIM: The kinetic turbidimetric Limulus test was used in the endotoxin assay of Ceftazidime injection. METHODS: The validation test was fulfiled, when the amount of endotoxin spiked in Ceftazidime injection sample (Lot. No. 010202) in which concentration of its dilution solution were 10, 5,2,1,0.5 g·L-1. They were recovered in 60.08%, 82.90%, 85.22%, 94.00%, 92.67%; with the amount of endotoxin spiked in Ceftazidime sample (Lot. No. 010103, 010104, 010202), their 1 g·L-1 dilution were recovered in 109.9%, 101.7% and 86.56%. RESULTS: With standard endotoxin working curve is 5.00, 0.500, 0.0500 ZU·L-1. The 1 g·L-1 solution to Ceftazidime was effective to eliminate the interference in Limulus test. CONCLUSION: The kinetic turbidimetric Limulus test provide a new way to the detection of endotoxin in Ceftazidime injection.