盐酸马尼地平原料药中杂质的结构确证及含量测定

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中图分类号：TB9 文献标志码：A文章编号：1674-5124（2025）07-0095-09

Abstract： Based on the synthetic process route，the impurities in the raw material of Manidipine hydrochloride were separated， confirmed structure and content determination. Agilent ZORBAX SB-C18（ 4.6m×250 mm， 5 μm） was used as a column. The detection wavelength was set at 229nm ，the column temperature was 40°C ， and the sample size was 20μL .Flow rate was 1mL/min ，mobile phase A was 0.01mol/L ammonium acetate solution，mobile phase B was acetonitrile， gradient elution.The experimental results showed that the byproduct of the synthesis process of Manidipine hydrochloride produced the impurity 5-（3-nitrophenyl）-3-methyl-2-cyclohexene-1-one under acidic conditions， and the impurity dehydromanidipine was produced under light irradiation. The linear relationships of Manidipine hydrochloride impurities were all good （r2⩾0.9997） in the concentration range. The RSDs of precision and solution stability tests were all less than 3.0%（n=6） .The average recoveries of the three impurities ranged from 97.47% to 102.56% ，and the RSDs were all less than 2.0%（n=9） . The study of these impurities is of great significance for the quality control of Manidipine hydrochloride.

Keywords： Manidipine hydrochloride; impurities; structural confirmation; content determination

0 引言

盐酸马尼地平是第三代二氢吡啶类钙离子拮抗剂，能够抑制L型和T型双通道钙离子，高选择抑制血管平滑肌中细胞电压，扩张动脉血管平滑肌，从而降低了血管外周阻力，起到降低血压作用[1-3]。（剩余15324字）