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目的合成2-乳酰氨基苯甲酸,并建立其有关物质的定量测定方法。方法 2-乳酰氨基苯甲酸以邻氨基苯甲酸甲酯为起始原料,经乳酰化后水解制成;有关物质测定采用RP-HPLC法,Diamonsil C18(250 mm×4.6 mm,5μm)色谱柱,以乙腈-体积分数1%乙酸水溶液为流动相,梯度洗脱,检测波长为250 nm。结果 2-乳酰氨基苯甲酸合成总收率为61.5%,其成品中有关物质总量低于0.5%,杂质A、B、C及单一未知杂质的含量质量分数均小于0.1%。结论 2-乳酰氨基苯甲酸合成与纯化工艺简单、成品纯度高;有关物质测定方法简单、灵敏、专属、耐用,可用于2-乳酰氨基苯甲酸有关物质的测定。
AIM: To synthesize 2-lactamidobenzoic acid and establish the quantitative determination method of its related substances. Methods The 2-lactamidobenzoic acid was prepared from methyl anthranilate and hydrolyzed by lactylation. The related substances were determined by RP-HPLC, Diamonsil C18 (250 mm × 4.6 mm, 5 μm) The column was eluted with a gradient of acetonitrile and 1% acetic acid in water. The detection wavelength was 250 nm. Results The overall yield of 2-lactamidobenzoic acid was 61.5%. The total amount of related substances in the finished product was less than 0.5%. The content of impurities A, B, C and single unknown impurities were less than 0.1%. Conclusion The synthesis and purification of 2-lactamidobenzoic acid is simple and the purity of finished product is high. The determination of related substances is simple, sensitive, specific and durable and can be used to determine the related substances of 2-lactamidobenzoic acid.