D. Xiaoqin
2013
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Journal
Progress in Pharmaceutical Sciences
Abstract
Objective:To establish a HPLC method for the determination of main component in active pharmaceutical ingredient(API) of azasetron hydrochloride.Methods:The external standard method was used.The analysis was performed on a Phenomenex Luna 5u C18(2)100A column.The mobile phase was composed of phosphate buffer solution and acetonitrile(82∶18),with the flow rate of 1.0 mL ·min-1.The detection wavelength and column temperature were 305 nm and 35 ℃,respectively.Results:The chromatographic peak area and concentration of azasetron hydrochloride showed a good linear relationship(r=0.999 9) at the range of 2.01-20.08 μg.Three batches of API samples contain azasetron hydrochloride of 99.6%,99.9% and 99.5%,respectively.The result was very close to that determined by nonaqueous titration.Conclusion:This method is accurate,convenient and oligosaprobic.It can be used for the determination of main component in API of azasetron hydrochloride.