高效液相色谱-蒸发光散射法测定白消安片的含量

Quantitative determination of content in Busulfan's tablets by HPLC-ELSD

目的:建立HPLC-ELSD法考察并测定白消安片中白消安的含量。方法:SHIMADZU C8柱(250mm × 4．6min,5μm),流动相:水:乙腈(75:25),流速:1．0mL／min,载气:氮气,载气流速:2．0bar。结果:白消安在浓度0．25-0．75mg／mL范围内与峰面积的对数呈良好的线性关系,r为0．999 9。平均回收率为99．7％。结论:本方法专属性好,准确,可用于该制剂中白消安含量的测定。

Objective： To establish a HPLC-ELSD method for determining the content of busulfan in busulfan tablets. Methods： The chromatographic conditions were as follows ： SHIMADZU Cs column（ 250mm ×4. 6mm ,5 μm）, the mobile phase ：water - acetonitrile （75： 25） ,the flow rate： 1 . 0mL/min,and the detector： ELSD, the carrier gas： nitrogen, the flow rate：2.0 bar. Results： The stand- ard curve of busulfan was linear over the rage of 0. 25 - 0. 75 mg/mL （ r = 0. 9999 ）. The average recovery was 99. 7 %. Conclusion： This method is accurate and specificity, and it can be used on the quality control of busulfan tablets.