对复方胆氨片标准中氨茶碱含量测定用对照品的探讨

Discussion on Reference Standard with Aminophylline Assay in Quality Standard of Compound Sodium Chlolate and Aminophylline Tablets

目的探讨、分析复方胆氨片标准中氨茶碱含量测定用对照品的合理使用。方法采用HPLC-PDA、UPLC-TOF MS,用保留值定性法和加入法比对、考察氨茶碱的液相色谱保留物与茶碱的关系。结果氨茶碱的液相色谱主峰与茶碱峰保留时间一致,紫外吸收光谱重合,折算成茶碱的峰响应因子相当,质谱准分子离子峰和碎片离子峰吻合,氨茶碱色谱主峰为茶碱峰。结论复方胆氨片质量标准中以茶碱对照品作为外标物测定含量,更科学合理。

OBJECTIVE To establish and evaluate the quality standard of Compound Sodium Chlolate and Aminophylline Tablets,using theophylline as external reference standard.METHODS The HPLC-PDA and UPLC-TOF-MS were employed to identify the main chromatographic peak of Aminophylline and Theophylline.The qualitative retention time and addition method were used for result comparison.RESULTS The major peak in the HPLC chromatogram of Aminophylline was identified to be Theophylline,based on evidences from the HPLC retention time,UV characters,HPLC correction factors,as well as the MS/MS data.CONCLUSION The developed method was applied successfully for the assessment of content of Compound Sodium Chlolate and Aminophylline.The result indicated that the method was more scientific and reasonable,using theophylline as external reference standard.