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HERO ID
2791156
Reference Type
Journal Article
Title
Stability indicating reversed-phase liquid chromatographic determination of metronidazole benzoate and diloxanide furoate as bulk drug and in suspension dosage form
Author(s)
Mishal, A; Sober, D
Year
2005
Is Peer Reviewed?
Yes
Journal
Journal of Pharmaceutical and Biomedical Analysis
ISSN:
0731-7085
EISSN:
1873-264X
Volume
39
Issue
3-4
Page Numbers
819-823
Language
English
PMID
16055294
DOI
10.1016/j.jpba.2005.05.029
Web of Science Id
WOS:000232209700069
Abstract
A selective, precise and accurate isocratic RP-HPLC method has been developed and validated for the simultaneous determination of metronidazole benzoate (MB), diloxanide furoate (DF), methyl paraben (MPn) and propyl paraben (PPn) in suspension. The cis/trans isomerization phenomenon for DF has also been presented. The method uses as stationary phase a Supelco LC-18 DB (15 cm x 4.6 mm) 5 microm column and as a mobile phase a buffer-acetonitrile mixture (70:30, v/v) adjusted to pH of 2.5 at a flow rate of 2.0 mLmin(-1). The buffer is a 0.005 M KH2PO4 solution. The four analytes were well resolved from the degraded solutions peaks. The excepients present in the formulation do not interfere with the assay procedure. The linearity range (n=3) is (0.20130-1.20779 mgmL(-1)) for MB with R of 0.99985; (0.15790-0.94740 mgmL(-1)) for DF with R of 0.99987; (0.01131-0.06788 mgmL(-1)) for MPn with R of 0.99987 and (0.00126-0.00756 mgmL(-1)) for PPn with R of 0.99991. Precision (n=6) was 0.87% for MB; 1.15% for DF; 1.32% for MPn and 1.27% for PPn. The percentage recoveries (n=3) were 99.1% for MB; 99.6% for DF; 99.1% for MPn and 98.7% for PPn. The proposed method can be utilized for the routine analysis of the four analytes in pharmaceutical dosage form.
Keywords
HPLC; metronidazole benzoate; diloxanide furoate; method development; method validation; isomerization
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