HPLC法测定4-氨基-2-三氟甲基苯基维甲酸酯原料药含量及有关物质

摘要

目的 采用高效液相色谱法建立4-氨基-2-三氟甲基苯基维甲酸酯(ATPR)原料药质量控制的方法.方法 色谱柱为大连伊利特Hypersil ODS 2柱(250 mm×4.6 mm,5μm),流动相为甲醇-水(92:8),检测波长为367 nm,柱温为30℃,流速约为1.0 ml· min-1.结果 主峰能与相邻杂质峰较好地分离,ATPR浓度在0.5～20 mg·L-1范围内线性关系良好(r=0.99 99,n=6).结论 该法简便、准确、专属性好,可以用于ATPR原料药的含量及有关物质的测定.%Aim To develop a HPLC method for the quality control of ATPR. Methods The separation was performed on a Hypersil ODS 2 column (250 mm×4.6 mm,5 μm). The mobile phase consisted of methanol-water (92 ∶8). The flow rate was 1. 0 ml·min -1. The UV detection was set at 367 nm. Results ATPR was completely separated from impurities. The calibrated linear curve of ATPR concentration was within 0. 5 ～ 20 mg · L-1 with the correlation coefficient of 0. 999 9. Conclusion This accurate and reliable HPLC method is applicable for the quality control of ATPR and its related substances.