Author(s): Mishal A, Sober D
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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.
This article was published in J Pharm Biomed Anal
and referenced in Pharmaceutica Analytica Acta