匹莫苯丹关键中间体含量测定方法的建立

Establishment of Assay Method for Key Intermediates of Pimobendan

为建立新兽药匹莫苯丹关键中间体6-(3,4-二氨基苯基)-4,5-二氢-5-甲基-3(2H)-哒嗪酮(DPDMP)的质量标准,本试验建立高效液相色谱法,用于测定DPDMP含量。本试验使用C18柱,以20 mmol/L醋酸铵缓冲液(醋酸调pH至5.5)-甲醇(75∶25,V/V)为流动相;流速为1.0 mL/min;进样量为10μL;检测波长为254 nm;柱温为25℃。结果显示:该中间体的峰面积与浓度呈良好的线性关系,加样平均回收率为99.52%,相对标准偏差RSD为0.86%。结果表明该方法方便、准确、可靠,适用于测定DPDMP的含量。

To establish a method for quality study of 6-(3,4-diaminophenyl)-4,5-dihydro-5-methyl-3(2H)-pyridazinone(DPDMP),a key intermediate of the new veterinary drug pimobendan,high performance liquid chromatography method was employed and used to determine the DPDMP content.In the experiment,C18 column was used with the mobile phase of 20 mmol/L ammonium acetate buffer(adjust the pH of acetic acid to 5.5)-methanol(75∶25,V/V);the flow rate was 1.0 mL/min;the injection volume was 10μL;the detection wavelength was 254 nm;the column temperature was 25℃.The result showed that the peak area of the intermediate had a good linear relationship with the concentration.The average recovery was 99.52%and RSD was 0.86%.Thus,this method is convenient,accurate and reliable,and can be used to determine the content of DPDMP.