高效液相色谱法测定脂溶性化妆品原料中的氨甲环酸杂质

Determination of Tranexamic Acid Impurity in Liposoluble Cosmetic Ingredients by High Performance Liquid Chromatography

采用高效液相色谱法测定脂溶性化妆品原料中的氨甲环酸杂质。样品用水饱和的二氯甲烷-无水乙醇混合溶液完全溶解并经缓冲盐溶液萃取后进行分析,采用资生堂SCX阳离子色谱柱（4.6 mm×250 mm×5μm）,以磷酸二氢钾溶液（用磷酸调pH至4.0）-水（60∶40,体积比）为流动相,检测波长为210 nm,柱温为45℃。结果表明,氨甲环酸在5~160μg/mL范围内线性关系良好,相关系数大于0.9997;方法检出限（S/N=3）为8 mg/kg;回收率为92.0%~107.7%,相对标准偏差（RSD,n=6）为0.5%~4.8%。

An analytical method to determine tranexamic acid impurity in liposoluble cosmetic ingredients by high performance liquid chromatography was established. The sample was completely dissolved in mixture of dichloromethane and anhydrous ethanol,which was saturated by water,and analyzed after extracted by buffer salt solution. The analysis was conducted on a SCX positive ion column（ 4.6 mm × 250 mm × 5 μm）,with potassium dihydrogen phosphate solution（ adjusting pH to 4. 0 by phosphoric acid）-water（ 60 /40,V /V） as the mobile phase. Detection wavelength was 210 nm and the column temperature was 45 ℃. Test results indicated that in the range of 5 to 160 μg / mL,the tranexamic acid showed a good linearity with correlation coefficient（ r） higher than 0. 9997. The detection limit of tranexamic acid was 8 mg / kg. The spiked recoveries of tranexamic acid were in the range of 92. 0% to 107. 7%,and the precision（ RSD） ranged from 0. 5% to 4. 8%（ n = 6）.