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    新型Gi蛋白偏向性阿片受体(MOR)激动剂LPM3480392原料药有关物质测定

    Determination of Related Substances in the Novel Gi Protein-biased Opioid Receptor(MOR) Agonist LPM3480392 Active Pharmaceutical Ingredients

      摘要
    • 摘要:
      目的  建立新型Gi蛋白偏向性阿片受体(MOR)激动剂LPM3480392的有关物质测定方法。
      方法 采用Waters Symmetry Shield RP18 (150 mm×4.6 mm，3.5 μm)色谱柱，以0.002 5 mol·L–1辛烷磺酸钠的0.01 mol·L–1磷酸二氢钾水溶液(含0.1%的三乙胺，磷酸调节pH 2.50)和乙腈为流动相，梯度洗脱，流速1.0 mL·min–1，紫外检测波长210 nm。
      结果 LPM3480392与杂质A、杂质B、杂质C、杂质E、杂质F的色谱峰能够完全分离。LPM3480392质量浓度在0.064 9~ 5.191 2 μg·mL–1内线性关系良好；杂质A、B、C、E、F质量浓度分别在0.066 6~7.610 4 μg·mL–1，0.166 0~3.794 0 μg·mL–1，0.209 2~4.463 2 μg·mL–1，0.167 9~7.672 6 μg·mL–1，0.016 4~7.505 7 μg·mL–1线性关系良好；回收率在93.0%~103.2%。
      结论 该方法可准确测定LPM3480392的有关物质，可为LPM3480392的后续研究与开发提供有价值的参考。

       

      Abstract:
      OBJECTIVE  To establish a determination method for the related substances of LPM3480392, a novel Gi protein-biased opioid receptor(MOR) agonist.
      METHODS  The separation was carried out with Waters Symmetry Shield RP18 (150 mm×4.6 mm, 3.5 μm) by gradient elution method, using a mixture of 0.002 5 mol·L–1 sodium 1-octanesulfonate monohydrate in 0.01 mol·L–1 potassium dihydrogen phosphate-water solution(containing 0.1% triethylamine, adjusted pH to 2.50 with phosphate acid) and acetonitrile as the mobile phase at a flow rate of 1.0 mL·min–1 and the UV detection wavelength was set at 210 nm.
      RESULTS  The chromatographic peaks of LPM3480392 and impurity A, impurity B, impurity C, impurity E and impurity F could be completely separated, the linear relationship of LPM3480392 was good in 0.064 9−5.191 2 μg·mL–1, while impurity A, impurity B, impurity C, impurity E and impurity F showed good linear relationship within 0.066 6−7.610 4 μg·mL–1, 0.166 0−3.794 0 μg·mL–1, 0.209 2−4.463 2 μg·mL–1, 0.167 9−7.672 6 μg·mL–1 and 0.016 4−7.505 7 μg·mL–1, respectively. The recovery rate was within 93.0%−103.2%.
      CONCLUSION  The method is suitable for the determination of related substances in LPM3480392, and can provide valuable reference for the follow-up research and development of LPM3480392.

       

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