HPLC法测定外用对乙酰氨基酚凝胶中对乙酰氨基酚的含量

Determination of Paracetamol in Paracetamol Gel for External Use by HPLC

目的:建立外用对乙酰氨基酚凝胶中对乙酰氨基酚的HPLC含量测定方法。方法:选用YMC-C18(150×4.6mm,5μm)色谱柱,流动相为甲醇-水-磷酸(22:78:0.1),检测波长为250nm,流速为1.0mL.min-1。结果:对乙酰氨基酚的量在0.04μg～0.14μg内与峰面积呈良好线性关系,相关系数r=0.9996,平均回收率为99.72%,RSD为0.73%。结论:方法操作简便,准确,灵敏度高,为外用对乙酰氨基酚凝胶质量控制提供了定量依据。

Objective：To establish a HPLC method for determinating paracetamol in Paracetamol Gel for External Use. Methods ：The YMC - C 18 （ 150 × 4.6 mm ,5 μm） column was used with a mobile phase of methanol - water - phosphoric acid （22：78：0.1 ） ,the flow rate maintained at 1.0mL·min^-1. The wave length of the detector was set at 250nm, Results： The calibration curve was linear over the range of 0.04μg - 0.14μg, The coefficient of relativity：r = 0. 9996 ,The average recoveries of paraeetamol was 99.72%, the relatieve standard deviation is 0.73%. Conclusions： The method is simple, accurate with a good sensitivity. It can be applied to the quality control of Paraeetamol Gel for External Use.