苯妥英钠液相含量测定方法的研究

Study on determination of phenytoin sodium in liquid phase

针对试验合成的苯妥英钠含量的测定问题,对色谱测定条件进行了考察及优化,建立了高效液相色谱测定含量测定苯妥英钠含量的方法,优化后色谱条件为:流动相为甲醇与水(体积比为57∶43),溶剂为(φ)50%甲醇,检测波长为220 nm,流速为1 mL/min,柱温为室温。在优化色谱条件下,该检测方法的精密度、重复性、稳定性结果均较好,精密度试验的RSD为1.53%,重复性试验RSD为0.95%,稳定性试验RSD为3.06%,具有检测时间短,易操作的优点,可用于对苯妥英钠试验合成产物含量的测定。

Aiming at the determination problems of phenytoin sodium synthesized in the experiment,the chromatographic determination conditions are investigated and optimized,and the HPLC method for the determination of phenytoin sodium is established.The optimized chromatographic conditions are as follows:the mobile phase is methanol and water(volume ratio 57∶43),and the solvent is(φ)50%methanol,the detection wavelength is 220 nm,the flow rate is 1 mL/min,and the column temperature is room temperature.Under the optimized chromatographic conditions,the results of precision,repeatability and stability of the method are good.The RSD of precision test is 1.53%,the RSD of repeatability test is 0.95%,and the RSD of stability test is 3.06%.The method has the advantages of short detection time and easy operation,which can be used to measure the content of phenytoin sodium.