Determination of Related Substances in the Novel Gi Protein-biased Opioid Receptor(MOR)Agonist LPM3480392 Active Pharmaceutical Ingredients
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.
万方数据
维普
