A method for the determination of related substances in safinamide mesylate based on method development software
10.19778/j.chp.2025.03.008
- VernacularTitle:一种基于方法开发软件建立的甲磺酸沙非胺的有关物质分析方法
- Author:
Qiong ZHU
1
;
Fenqin CHEN
1
;
Lei NI
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:
safinamide mesylate;
ACD labs/autochrom;
related substances;
HPLC method
- From:
Drug Standards of China
2025;26(3):285-293
- CountryChina
- Language:Chinese
-
Abstract:
Objective:With the help of the advanced ACD Labs/AutoChrom method development software,param-eter simulation design was carried out.Based on the results of software simulation and actual investigation,an HPLC method for the determination of related impurities in safinamide mesylate raw material drug was established.Methods:A Waters Atlantis T3 column(4.6 mm ×250 mm,5 μm)was used.The phosphate buffer with a pH of 7.0 was used as mobile phase A,and acetonitrile was used as mobile phase B.Gradient elution was performed at a flow rate of 1.3 mL·min-1,the detection wavelength was 228 nm,the column temperature was 35 ℃,and the injection volume was 10 μL.Results:Impurities 1-12 in safinamide mesylate could be effectively separated from the main component.The linear ranges were 0.102 1-5.329,0.102 9-5.379 7,0.106 8-4.972 9,0.102 1-5.135,0.103 8-5.314 7,0.097 7-4.869 8,0.095 2-4.760 5,0.095 3-5.109 5,0.050 5-5.287 5,0.098 7-4.885 6,0.102 4-4.997 5,0.050 8-5.134 7 μg·mL-1,respectively.The limits of detection(LOD)were 0.051,0.051 4,0.053 4,0.051 1,0.051 9,0.048 8,0.047 6,0.047 7,0.025 3,0.049 3,0.051 2,0.025 4 μg·mL-1,and the limits of quantification(LOQ)were 0.102 1,0.102 9,0.106 8,0.102 1,0.103 8,0.097 7,0.095 2,0.095 3,0.050 5,0.098 7,0.102 4,0.050 8 μg·mL-1.The accuracy,preci-sion and durability all met the requirements.Conclusion:This method is suitable for the determination and quality control of the related substances of 12 impurities in safinamide mesylate raw materials.
