Tian Gui-rong
2007
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Journal
West China Journal of Pharmaceutical Sciences
Abstract
OBJECTIVE To develop a method for the determination of high molecular weight impurities in Sulbenicillin sodium.METHODS HPLC method was adopted.Sephadex G10 gel column and mobile phase A of 0.05 mol·L-1 phosphate buffer(pH7.0),and Phase B of super pure water were employed.The flow rate was 1.0 ml·min-1.The detection wavelength was set at 254 nm,and the column temperature was 25℃.RESULTS The content of the high molecular weight impurities in Sulbenicillin sodium was less than 0.12%.CONCLUSION The method is simple,rapid and reliable.It can be applied to the quality control of Sulbenicillin sodium.