CAJ | 학술논문

目的：建立高效液相色谱法测定阿法替尼片含量的方法。方法采用Phenomenex Luna C18色谱柱（4.6 mm ×250 mm，5μm），流动相为0.02 mol·L-1磷酸二氢钾（2 mol·L-1氢氧化钠溶液调pH 6.0）-乙腈（50：50），柱温为30℃，检测波长为252 nm，流速为1.0 mL·min-1。结果阿法替尼浓度在20~120μg·mL-1范围内线性关系（r＝0.9999）良好，平均回收率为100.3%，RSD为0.93%。结论本方法专属强，准确度高，简便，快速。
목적：건립고효액상색보법측정아법체니편함량적방법。방법채용Phenomenex Luna C18색보주（4.6 mm ×250 mm，5μm），류동상위0.02 mol·L-1린산이경갑（2 mol·L-1경양화납용액조pH 6.0）-을정（50：50），주온위30℃，검측파장위252 nm，류속위1.0 mL·min-1。결과아법체니농도재20~120μg·mL-1범위내선성관계（r＝0.9999）량호，평균회수솔위100.3%，RSD위0.93%。결론본방법전속강，준학도고，간편，쾌속。
Objective To establish an HPLC method for the determination of Afatinib Tablets. Methods A stable HPLC method was established,and the chromatography was accomplished on Phenomenex Luna C18 column(4. 6 mm × 250 mm,5 μm),the mobile phase consisted of 0. 02 mol·L-1 of potassium dihydrogen phosphate( adjusted to pH 6. 0 with 2 mol·L-1 sodium hydroxide solution)-acetonitrile( 50:50 ),the column temperature was 30 ℃,the detection wavelength was 252 nm and the flow rate was 1. 0 mL·min-1. Results The linear range of afatinib was 20~120 μg·mL-1(r=0. 999 9),the average recovery was 100. 3% with corresponding RSD of 0. 93%. Conclusion The method was specific,ac-curate,convenient and rapid.