UPLC与HPLC测定泛昔洛韦原料药中有关物质的比较研究

A Comparison of Determination of Related Substances in Famciclovir by UPLC and H PLC

目的:建立测定泛昔洛韦有关物质的超高效液相色谱法(UPLC),并与其高效液相色谱法(HPLC)进行比较。方法:UPLC法,采用WatersAcquityUPLCBEHC18色谱柱(100mm×2.1mm,1.7μm),流流速为0.4mL·min^-1;HPLC:采用WatersunfireC8色谱柱(250mm×4.6mm,5μm),流速为1mL·min^-1。两方法均以磷酸二氢钾溶液和乙腈的不同比例的混合液为流动相进行梯度洗脱,检测波长220nm,柱温40℃。结论:UPLC和HPLC2种方法重复性、线性等验证结果以及样品测定结果基本一致;UPLC相比HPLC有更高的分析效率,更高的灵敏度,更环保。

To develop and validate a stability UPLC method for the simultaneous determination of six related substances in fanciclovir drug substance, and to compare it with HPLC method as well as the determination results. Methods: The UPLC separation was performed on waters Acquity UPLC BEH C18 chromatographic column (100 mm×2.1 mm, 1.7 μm), using gradient elution of acetonitrile and potassium dihydrogen phosphate buffer as mobile phase at a flow rate of 0.4 mL·min^-1. The HPLC method was conducted on Waters sunfire C8 chromatographic column (250 mm×4.6 mm, 5 μm), with flow rate was 1 mL·min^-1. The wavelength and column temperature were set at 220 nm and 40 ℃, respectively in both methods. In order to compare the differences between two methods with respect to resolution, linearity repeatability, recovery, limit of detection, limit of quantification, force degradation tests, stability and the content of the seven compounds were investigated. Conclusion: Both of the methods show almost the same results. The UPLC method is more efficient, accurate, sensitive and environmental protective.