Determination of Related Substances in the Novel Gi Protein-biased Opioid Receptor(MOR) Agonist LPM3480392 Active Pharmaceutical Ingredients
10.13748/j.cnki.issn1007-7693.20222657
- VernacularTitle: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
- Author:
Congrui FENG
1
;
Lixia LI
1
;
Dan WANG
2
;
Shuping WANG
3
;
Lianqing ZHANG
3
;
Zhihong XU
1
,
3
;
Fengmei ZHOU
3
;
Xin CHE
1
,
3
Author Information
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
- Publication Type:Journal Article
- Keywords:
analgesic drugs;
Gi protein-biased opioid receptor;
LPM3480392;
related substances;
HPLC
- From:
Chinese Journal of Modern Applied Pharmacy
2024;41(3):372-377
- CountryChina
- Language:Chinese
-
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.
