高效液相色谱法测定2-(2,6-二氯苯基氨基)苯乙酸-4-(4-苯基-1,2,5-噁二唑-2-氧化物-3-)甲氧基苯甲酯原料药的研究

Study on Determination of ZLR-8 by HPLC

目的 采用反相高效液相色谱法建立2-（2，6-二氯苯基氨基）苯乙酸-4-（4-苯基-1，2，5-噁二唑-2-氧化物-3-）甲氧基苯甲酯（ZLR-8）原料药质量控制的方法。方法色 谱柱为LichrospherODS柱（4．6mm×250mm），流动相为甲醇-乙腈-2-（55：20：10），检测波长为226nm，流速为1．0mL·min^-1。结果 中间体及各降解产物对样品测定不产生干扰，ZLR-8的浓度为11．18～223．6mg·L^-1时与峰面积呈良好线性关系（r=0．9998，n=5），重复性良好（RSD％=0．47，n=6），检测限为54μg·L^-1。结论 该方法可以用于ZLR-8原料药的含量测定和有关物质检查。

OBJECTIVE To develop a RP-HPLC method for the quality control of （ZLR-8） .METHODS The separation was performed on a Lichrospher ODS column（4.6 mm × 250 mm）, The mobile phase consisted of methanol-acetonitrile-water（55：20： 10）. The flow rate was 1.0 mL·min^- 1. The UV detection was set at 226 nm. RESULTS The intermediates and compounds produced by degradation did not interfere ZLR-8,A good linearity was found over the concentration range of 11.18 to 223.6 mg·L^-1, the RSD for the repeatability was 0.47% （ n = 6）, the limit of detection for ZLR-8 was 54 μg·L^- 1. CONCLUSION The method is simple and accurate.