HPLC法测定盐酸阿扎司琼原料药中主药含量

Determination of Main Component in Active Pharmaceutical Ingredient of Azasetron Hydrochloride by HPLC

目的:建立HPLC法测定盐酸阿扎司琼原料药中的主药含量。方法:采用外标法,使用Phenomenex Luna5u C18(2)100A色谱柱(250 mm×4.6 mm,5μm),磷酸盐缓冲液-乙腈(82∶18)为流动相,流速为1.0 mL.min-1,检测波长为305 nm,柱温为35℃。结果:盐酸阿扎司琼进样质量在2.01～20.08μg范围内,与色谱峰面积的线性关系良好(r=0.999 9)。测得3批原料药中盐酸阿扎司琼质量分数分别为99.6%、99.9%和99.5%,与非水滴定法的测定结果相近。结论:该法准确、便捷、低污染,可用于盐酸阿扎司琼原料药中主药含量的测定。

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 wave]ength and column temperature were 305 nrn and 35 ℃, respeciively. 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 vel7 close to that determined by nonaqueous titration. Conclusion： This method is accurate, convenient and oligosaprobic. It can be used for the deter- mination of main component in API of azasetron hydroehloride.