Determination of secnidazole and its related substances by HPLC
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Graphical Abstract
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Abstract
Aim :To establish an HPLC method for the determination of secnidazole and its related substances,and to elucidate the structure of the main related substances. Methods :HPLC was performed on an Agilent C18(150 mm×4.6 mm,5 μm)column.The mobile phase consisted of acetonitrile and 0.1% formic acid solution(10∶90).The detection wavelength was set at 320 nm and the column oven was maintained at 30 °C.The mass spectrometry detector was equipped with an ESI source with a temperature of 350 °C,and set at positive ion monitoring model.The spray chamber pressure was 0.34 MPa. The drying gas flow rate was 10 L/min. Results :Secnidazole was completely separated from the impurities.The calibration curve of secnidazole was linear over the range of 0.10-1 500.0 μg/mL with the correlation coefficient of 0.999 9.The contents of secnidazole in the samples were 100.5%,100.3% and 100.7%,respectively,and those of the related substances were 0.463%,0.488% and 0.465%,respectively.The three related substances were identified by HPLC-UV-MSn as 2-methyl-5-nitroimida-zole and the isomerides of secnidazole,respectively. Conclusion :The developed method is reliable for the quality control and determination of related substances of secnidazole.
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