摘要:
为建立测定芒柄花素磺酸钠有关物质的方法,采用高效液相色谱法,色谱柱为Agilent HC-C18(250mm×4.6 mm,5μm),流动相A为乙腈,流动相B为0.01 mol/L的磷酸二氢钾,流速为0.8 mL/min,按照梯度洗脱,进样量为10 μL,检测波长为250 nm,柱温为30℃.结果表明:主药与各杂质、各杂质之间分离度良好,各杂质均能被有效检出;芒柄花素磺酸钠及杂质A,B,C,D,E,F和G的质量浓度分别在0.060~4.004(r=0.999 8),0.056~3.756(r=0.999 3),0.039~3.902(r=0.999 6),0.060~4.026(r=0.999 5),0.058~3.878(r=0.999 3),0.058~3.869(r=0.999 5),0.060~3.977(r=0.999 5)和0.040~3.952 μg/mL(r=0.999 4)范围内与各自峰面积呈良好的线性关系;仪器精密度、中间精密度、稳定性试验的RSD值小于2.0%;各杂质测定的平均回收率为98.49%~101.76%,RSD值为0.37%~1.37%(n=9).本方法专属性强、准确度高、耐用性良好,可用于芒柄花素磺酸钠有关物质的测定.