Chemical stability of cefotetan disodium in 5% dextrose and 0.9% sodium chloride injections

J Clin Pharm Ther. 1990 Apr;15(2):109-14. doi: 10.1111/j.1365-2710.1990.tb00364.x.

Abstract

The chemical stability of cefotetan disodium in 5% dextrose and 0.9% sodium chloride injections has been studied using a stability-indicating high-pressure liquid chromatographic (HPLC) assay method. The drug appears to be relatively unstable at 25 degrees C (expiry time 2 days), compared with at least 41 days at 5 degrees C and at least 60 days at -10 degrees C. Thawing the frozen samples in a microwave (90 s) did not cause any significant decomposition. The manufacturer's recommended expiry time of 4 days at 5 degrees C and at least 7 days at -10 degrees C is very conservative. The HPLC method developed is accurate and precise with a relative percentage standard deviation of 1.7 based on six readings. The method appears to be stability-indicating as the samples decomposed under drastic conditions had almost no drug left and new peaks were observed in the chromatograms.

MeSH terms

  • Cefotetan / analysis*
  • Chromatography, High Pressure Liquid
  • Drug Stability
  • Injections
  • Temperature

Substances

  • Cefotetan