高效液相色谱法测定6-APA的相关物质

采用高效液相色谱法测定6-APA中可能存在的杂质。方法按照《中国药典》2010年版。流动相为0.1 mol/L磷酸盐缓冲液乙腈（80∶20）,稀释液为pH=5.5的磷酸盐缓冲液,流速为1.0 mL/min,检测波长为224 nm,进样量为20μL,柱温为35℃。结果表明,该检测方法具有较强专属性,线性很好,杂质A、B的相关系数分别为0.999 4、0.999 1,准确回收率分别为98.1%、95.8%,定量限分别为9.992 6×10-8、1.004 8×10-7,检测限分别为3.330 9×10-8、3.349 1×10-8,杂质的相关条件符合规定。该方法简便、易行,结果准确。

Determination on Related Substances of 6-APA by HPLC Method

According to Chinese Pharmacopoeia 2010,to establish a HPLC analytical method for determining the potential impurities of 6-APA.The detail conditions were as follows： mobile phase was a suitable mixture solution of phosphate buffer an acetonitrile（80∶20）,diluent was phosphate buffer solution of pH 5.5,flow rate was 1.0 mL/min;wavelength was 254 nm,injection volume was 50 μL,column temperature was 35 °C.The method had good specificity and linearity.The correlation coefficient of impurity A and impurity B were 0.9994 and 0.9991,the recovered rate were 98.1% and 98.5%,the LOQ were 9.992 6×10-8 and 1.004 5×10-8,the LOD were 3.330 9×10-8 and 3.349 1×10-8.According to the program,all the items had a good validation.The method is simple,accurate,repeatable,and can be used for the quality control of theimpurities of 6-APA.