ACD/AutoChrom-assisted method development for detection of related substances in buprenorphine API
10.19778/j.chp.2025.03.007
- VernacularTitle:ACD/AutoChrom辅助丁丙诺啡原料药有关物质检测方法的建立
- Author:
Yaqin ZHANG
1
;
Fengqin CHEN
1
;
Bo JI
1
;
Guihua LU
1
;
Haoli SUN
1
;
Chunyan SUN
1
;
Huimin LYU
1
;
Ruwei WANG
1
Author Information
1. 扬子江药业集团有限公司,江苏泰州 225300;克服递药屏障高端制剂全国重点实验室,江苏泰州 225300
- Publication Type:Journal Article
- Keywords:
buprenorphine;
ACD Labs/AutoChrom;
related substances determination;
HPLC
- From:
Drug Standards of China
2025;26(3):278-284
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish a high-performance liquid chromatography(HPLC)method for the determina-tion of related substances in buprenorphine active pharmaceutical ingredient(API)using advanced ACD/Auto-Chrom method development software for comprehensive parameter simulation and design.Methods:An Agilent ZORBAX Eclipse Plus C18 column(4.6 mm × 150 mm,3.5 μm)was used with a mobile phase consisting of 40 mmol·L-1 potassium dihydrogen phosphate solution and acetonitrile in a gradient elution mode.The flow rate was set at 1.3 mL·min-1,the column temperature was maintained at 35 ℃,the detection wavelength was 240 nm,and the injection volume was 5 μL.Results:The impurities A,B,D,E,F,G,H,I,and J in buprenorphine were effectively separated from the main component.The linear ranges were 0.33-83.73,0.20-78.74,0.20-40.28,0.22-43.31,0.32-78.98,0.13-63.74,0.51-101.54,0.22-43.72,and 0.40-80.37 μg·mL-1,respectively.The limits of detection(LOD)were 0.10,0.06,0.06,0.06,0.09,0.04,0.15,0.07,and 0.12 μg·mL-1,respectively,while the limits of quantification(LOQ)were 0.33,0.20,0.20,0.22,0.32,0.13,0.51,0.22,and 0.40 μg·mL-1,respectively.The accuracy,precision,and robustness of the method met the required standards.Conclusion:This method is suitable for the determi-nation and quality control of related substances such as impurities A,B,D,E,F,G,H,I,and J in buprenorphine API.
