Determination of Balsalazide Tablet and Detection of Its Related Substances by HPLC / 中国药房

ABSTRACT

OBJECTIVE:To establish a HPLC method for the determination of the principal agent in balsalazide tablets and detection of the related substances.METHODS:The determination was conducted on C18 column with column temperature at 40℃.The mobile phase was composed of 0.1 mol/L ammonium dihydrogen phosphate-acetonitrile(82∶18) with flow rate at 1.0ml/min and wavelength at 360nm.RESULTS:Balsalazide and its related substance could be absolutely separated through this method.The liner range of the balsalazide was 20.0～150.0?g/ml(r=0.9 999).The average recovery was 99.6%(RSD=1.19%).CONCLUSION:The method was simple,fast,accurate,specific,reproducible and free from the interference of excipients in the determination of principal agent,and which can be adopted for the determination of the principal agent in balsalazide tablets and detection of the related substances.