Development and validation of liquid chromatographic method for metronidazole

A simple isocratic, rapid and sensitive high performance liquid chromatographic method has been developed for quantitative determination of Metronidazole and its process related impurity. The method has been validated for determination of related substance in metronidazole using C8 ODS (250X4.6mm) column by keeping the flow rate of 1ml/min and having sensitivity of 4.The elution is carried out by using mobile phase of 300ml acetonitrile,200ml methanol, 100ml THF and 400 ml water(1.56gms/litre K2HPO4). pH is adjusted to 11 by TEA. The detection is carried out at 254nm with injection volume of 10 microliter. Specificity, system suitability, linearity, precision, ruggedness, robustness has been carried out for metronidazole. Limit of quantification and limit of detection has been carried out for the impurities of metronidazole.

Author(s): Nandini R. Pai

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