| 引用本文: | 冯聪睿,王丹,李丽霞,王淑萍,张连庆,徐志红,周凤梅,车鑫.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[J].中国现代应用药学,2024,41(3):372-377. |
| FENG Congrui,WANG Dan,LI Lixia,WANG Shuping,ZHANG Lianqing,XU Zhihong,ZHOU Fengmei,CHE Xin.Determination of Related Substances in the Novel Gi Protein-biased Opioid Receptor(MOR) Agonist LPM3480392 Active Pharmaceutical Ingredients[J].Chin J Mod Appl Pharm(中国现代应用药学),2024,41(3):372-377. |
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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 |
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冯聪睿1, 王丹2, 李丽霞1, 王淑萍3, 张连庆3, 徐志红1,3, 周凤梅3, 车鑫1,3
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1.烟台大学药学院分子药理和药物评价教育部重点实验室，新型制剂与生物技术药物研究山东省高校协同创新中心，山东 烟台 264005;2.沈阳市食品药品检验所，沈阳 110000;3.绿叶制药有限公司长效和靶向制剂国家重点实验室，山东 烟台 264003
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| 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。 |
| 关键词: 镇痛药物 Gi蛋白偏向性阿片受体激动剂 LPM3480392 有关物质 高效液相色谱法 |
| DOI：10.13748/j.cnki.issn1007-7693.20222657 |
| 分类号:R917 |
| 基金项目: |
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| Determination of Related Substances in the Novel Gi Protein-biased Opioid Receptor(MOR) Agonist LPM3480392 Active Pharmaceutical Ingredients |
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FENG Congrui1, WANG Dan2, LI Lixia1, WANG Shuping3, ZHANG Lianqing3, XU Zhihong1,3, ZHOU Fengmei3, CHE Xin1,3
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1.Key Laboratory of Molecular Pharmacology and Drug Evaluation, Ministry of Education, Collaborative Innovation Center of Advanced Drug Delivery System and Biotech Drugs in Universities of Shandong, School of Pharmacy, Yantai University, Yantai 264005, China;2.Shenyang Institute for Food and Drug Control, Shenyang 110000, China;3.State Key Laboratory of Long-acting and Targeting Drug Delivery System, Shandong Luye Pharmaceutical Co., Ltd., Yantai 264003, China
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| 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. |
| Key words: analgesic drugs Gi protein-biased opioid receptor LPM3480392 related substances HPLC |
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