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=0.999 9,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（928）.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.
出处
《安徽医药》
CAS
2011年第9期1073-1076,共4页
Anhui Medical and Pharmaceutical Journal
基金
安徽高等学校省级自然科学研究项目(NoKJ2010B376)
