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CHEMICAL STABILITY OF CEFOTETAN DISODIUM IN 5% DEXTROSE AND 0.9% SODIUM CHLORIDE INJECTIONS
Author(s) -
Gupta V. Das,
Pramar Y.,
Odom C.,
Zerai T.,
Bethea C.
Publication year - 1990
Publication title -
journal of clinical pharmacy and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.622
H-Index - 73
eISSN - 1365-2710
pISSN - 0269-4727
DOI - 10.1111/j.1365-2710.1990.tb00364.x
Subject(s) - chromatography , chemistry , cefotetan , high performance liquid chromatography , sodium , relative standard deviation , antibiotics , detection limit , organic chemistry , biochemistry , antibiotic resistance , imipenem
Summary 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 o C (expiry time 2 days), compared with at least 41 days at 5 o C and at least 60 days at ‐10 o 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 o C and at least 7 days at ‐10 o 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.