摘要
目的应用高效液相色谱法建立马来酸阿法替尼片溶出度的测定方法。方法溶出度采用桨法,以pH 4.0磷酸盐缓冲液900m L为溶出介质,转速为75r·min^(-1)。用十八烷基硅烷键合硅胶为填充剂(CAPCELL PAK MGⅡ,250mm×4.6mm,5μm),以0.05mol·L^(-1)甲酸铵(甲酸调节pH至4.5)-甲醇(31∶69)为流动相。流速为1.0m L·min^(-1);检测波长为254nm,柱温为35℃,进样量10μL。结果马来酸阿法替尼在0.37~149.9μg·m L^(-1)浓度范围内线性关系良好(R2=0.999),精密度良好(RSD=0.52%),溶液在12h内稳定(RSD=0.54%),平均回收率为99.8%(RSD=0.30%)。结论该方法准确、简便。
OBJECTIVE To establish a high performance liquid chromatography （HPLC） method for the disso- lution of afatinib dimaleate tablets. METHODS Paddle method was used in the dissolution test with 900mL of pH 4. 0 buffer as the medium at the rotation speed of 75r · min-1. An CAPCELL PAK MG II C18 column（250mm×4.6mm,5μm） was used for the separation. The mobile phase consisted of 0. 05mol · L-1ammonium formate （pH was adjusted to 4. 5 with formic acid）and methanol （31：69 ） at the flow rate of 1.0mL·min-1, the detective wavelength was 254nm, and the column temperature was 40℃. The injection volume was 10μL. RESULTS Afatinib dimaleate showed a good linear relationship within the range of 0. 37 - 149.9μg · mL-1 （ R2 = 0. 999 ） , the precisions and 12- hour stability were satisfactory with RSD 0. 52% and 0. 54% respectively ,the average recovery was 99.8% （RSD = 0. 30% ）. CONCLUSION This method is accurate, fast.
出处
《海峡药学》
2017年第6期42-45,共4页
Strait Pharmaceutical Journal
