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Stability of metronidazole benzoate in suspensions
Author(s) -
Mathew M.,
Gupta V. Das,
Bethea C.
Publication year - 1994
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.1365-2710.1994.tb00805.x
Subject(s) - metronidazole , chromatography , acetonitrile , chemistry , solubility , hydrolysis , high performance liquid chromatography , elution , base (topology) , organic chemistry , antibiotics , biochemistry , mathematical analysis , mathematics
A stability‐indicating HPLC assay method has been developed to quantify metronidazole benzoate in suspensions. A study of the stabilities of two suspensions (16‐0 mg/ml) of metronidazole benzoate in commercially available vehicles, Ora‐Plus and a mixture of Ora‐Plus and Ora‐Sweet, showed that both suspensions were stable for at least 90 days at room temperature. The mobile phase required to elute metronidazole benzoate contained 40% acetonitrile versus approximately 10% for the free base. The solubility of the ester in water at 25d̀C was found to be approximately 0‐1 mg/ml versus 10 mg/ml for the free base. The ester did not hydrolyse significantly to the free base after storage for 8 h at 37d̀C in simulated gastric fluid, and 5 h at 37d̀C in simulated intestinal fluid. The bitter tasting metronidazole may not be satisfactorily substituted with its tasteless ester in the treatment of local gastrointestinal infections.