匹莫苯丹对照品的定值研究

Assignment of Pimobendan Chemical Reference Substance

关键词:  匹莫苯丹  质量平衡法  容量法  高效液相色谱法

Key words:  Pimobendan  mass balance method  volumetric method  HPLC external standard method

摘要:

为了研制匹莫苯丹对照品,采用精制后的匹莫苯丹为原料,并进行质量评价。采用熔点法、红外分光光度法、液相色谱法对原料进行鉴别,采用质量平衡法定值,同时采用容量法和高效液相色谱法加以佐证。结果显示,以质量平衡法计算其含量为99.8%,容量法测定含量为99.7%,液相色谱外标法测定含量为99.6%,三种方法测定结果一致。本次研制的匹莫苯丹对照品可用于匹莫苯丹及其制剂的鉴别与含量测定。

Abstract:

To develop the national reference of pimobendan. The refined pimobendan was used as raw material and the quality inspection was tested. The raw materials were identify by melting point, infrared spectrophotometry and HPLC. The content of pimobendan was determine by the mass balance method, volumetric method and HPLC external standard method. The result show that, the content of pimobendan was 99.8% by mass balance method, was 99.7% by volumetric method and was 99.6% by HPLC external standard method. The three determined contents were in accordance with each other. The reference of pimobendan in this study can be used for the identification of the preparations of pimobendan