Simultaneous Determination of Metronidazole and Furazolidone in Combined Tablet Dosage Form: Development and Validation of a Stability Indicating HPLC Method

摘要

A sensitive, precise and accurate stability-indicating HPLC with ultra violet detection method has been developed for simultaneous determination of metronidazole and furazolidone. Chromatographic separation was achieved on a Purospher~R Star RP-8 column (250 mm x 4.6 mm; 5 μm particle size) by a mobile phase consisted of acetonitrile and water (90:10, v/v) with a flow rate of O.S mL/min. The detection wavelength was set at 332 nm. Metronidazole and furazolidone was subjected to different forced degradation conditions. In all the conditions, the degradation products were well resolved from the peaks of metronidazole and furazolidone. The method was linear at a concentration range of 30 μg/mL to 90 μg/mL (R2=0.9999) and 10 μg/mL to 30 μg/mL (R2=0.9996) for metronidazole and furazolidone, respectively. The limit of quantitation was 0.793 μg/mL and 0.230 μg/mL for metronidazole and furazolidone, respectively. The precision of the method was satisfactory;; the relative standard deviations values did not exceed 1%. The accuracy of the method was proved;; the mean recovery of metronidazole and furazolidone was in the range of 99.66% to 100.28%. The developed and validated method was applied successfully for the assay of metronidazole and furazolidone in combined tablet dosage with good precision and accuracy.