ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF SIMULTANEOUS ESTIMATION OF METRONIDAZOLE AND DILOXANIDE FUROATE IN TABLET DOSAGE FORM BY RP-HPLC
Journal Title: Int J of Preclin & Pharm Res - Year 2014, Vol 4, Issue 7
Abstract
ABSTRACT A simple, precise, rapid, specific and accurate reverse phase high performance liquid chromatography method was developed for simultaneous estimation of Metronidazole and diloxanide furoate in pharmaceutical dosage form. Chromatographic separation was performed on Inertsil ODS 3V, 4.6x250mm, 5μm column, with mobile phase comprising of mixture of buffer (pH 5.5, adjusted with phosphate buffer), acetonitrile and methanol in the ratio of 30:20:50 v/v, at the flow rate 1 ml/min. The detection was carried out at 241 nm. The retention times of Metronidazole and diloxanide furoate were found to be 2.2 and 3.7 mins respectively with a run time of 6 mins, theoretical levels for Metronidazole and diloxanide furoate were 3351 and 5094 respectively, with a resolution of 8.422. As per ICH guidelines the method was validated for linearity, accuracy, precision, limit of detection and limit of quantitation, robustness and ruggedness. Linearity of Metronidazole was found in range of 60-140 µg/mL and that for Diloxanide furoate was found to be 75-175 µg/mL. The correlation coefficient for Metronidazole and diloxanide furoate was 0.99 and 0.99 respectively. The LOD values for Metronidazole and diloxanide furoate were 6.89 and 3.92 µg/mL respectively. The LOQ values for Metronidazole and diloxanide furoate were and 20.87 and 11.88 µg/mL respectively. This demonstrates that the developed method is simple, precise, rapid, selective, accurate and reproducible for simultaneous estimation of Metronidazole and diloxanide furoate tablet dosage form. Keywords: Metronidazole, Diloxanide furoate, RP-HPLC, Validation.
Authors and Affiliations
Kalpana MJ*, Naga sowjanya G, Ajitha A, Uma Maheshwara Rao V
Keywords
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