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目的 建立HPLC测定D-对羟基苯甘氨酸甲酯中潜在的手性杂质[杂质1:L-对羟基苯甘氨酸,杂质2:L-对羟基苯甘氨酸甲酯,杂质3:D-对羟基苯甘氨酸]的含量和限度.方法 采用Crownpak CR(-)手性色谱柱(150 mm×4.0 mm,5μm);流动相:高氯酸溶液(pH 1.7)-甲醇(90∶10);检测波长为226 nm;流速:0.7 mL·min-1;柱温:25℃.结果 杂质1、杂质2和杂质3均在其定量限浓度～2.400 μg·mL-1内线性良好(r分别为1.000 0,0.999 9,0.999 9),平均回收率分别为99.97％,100.30％和103.18％,RSD分别为0.30％,0.64％和0.62％(n=9).结论 该方法专属性强,准确、方便,可以作为D-对羟基苯甘氨酸甲酯中手性杂质1、杂质2和杂质3的液相分析方法.“,”OBJECTIVE To establish a method of HPLC to determine the limit and content of potential chiral impurities:L-hydroxy phenyl glycine (impurity 1),L-hydroxyphenylglycine methyl ester (impurity 2) and D-hydroxyphenylglycine (impurity 3) in active pharmaceutical substance D-hydroxyphenylglycine methyl ester qualitatively and quantitatively.METHODS A Crownpak CR(-) chiral column (150 mm×4.0 mm,5 μm) was used,with perchlorate solution (pH 1.7)-methanol (90 ∶ 10) as the mobile phase with a flow rate at 0.7 mL·min-1.The detection wavelength was 226 nm,and the temperature of column was 25 ℃.RESULTS The calibration curve for impurity 1,impurity 2 and impurity 3 were well linear in the range of LOQ concentration-2.400 μg·mL-1 (r were 1.000 0,0.999 9 and 0.999 9,respectively).Average recoveries for impurity 1,impurity 2 and impurity 3 were 99.97％,100.30％ and 103.18％,and RSDs were 0.30％,0.64％ and 0.62％ (n=9),separately.CONCLUSION The method is highly specific,accurate and convenient,it can be used for the quality control of the chiral impurities 1,impurities 2 and impurities 3 of D-hydroxyphenylglycine methyl ester.