Comparison of SEC-RI-MALLS and SEC-RID methods for determining molecular weight and molecular weight distribution of PLGA
10.19778/j.chp.2025.01.016
- VernacularTitle:SEC-RI-MALLS和SEC-RID测定丙交酯乙交酯共聚物相对分子质量及相对分子质量分布的方法比较
- Author:
WANG Baocheng
;
ZHANG Xiaoyan
;
ZHOU Xiaohua
;
ZHAO Xun
;
MA Congyu
;
GAO Zhengsong
;
SHI Haiwei
;
YUAN Yaozuo
;
HANG Taijun
- Publication Type:Journal Article
- Keywords:
multi-angle laser light scattering;
size exclusion chromatography;
differential refractive index detector;
Poly(Lactide-co-Glycolide Acid);
PLGA;
molecular weight and distribution
- From:
Drug Standards of China
2025;26(1):110-116
- CountryChina
- Language:Chinese
-
Abstract:
Objective: To establish a method for determining the molecular weight and molecular weight distribution of Poly(Lactide-co-Glycolide Acid) (PLGA) using Size Exclusion Chromatography-Refractive Index-Multiangle Laser Light Scattering (SEC-RI-MALLS) and Size Exclusion Chromatography-Refractive Index (SEC-RID), and to compare the results obtained from these two methods.
Methods: For SEC-RI-MALLS, tetrahydrofuran was used as the mobile phase, Shodex GPC KF-803L was employed as the chromatographic column with a flow rate of 1 mL·min-1, column temperature at 30 ℃, and an injection volume of 100 μL. For SEC-RID, tetrahydrofuran was also used as the mobile phase, Agilent PLgel 5 μm MIXD-D was used as the chromatographic column with a flow rate of 1 mL·min-1, column temperature at 30 ℃, differential detector temperature at 35 ℃, and an injection volume of 20 μL. The molecular weight and molecular weight distribution were calculated using Agilent’s GPC software. The newly established methods were validated methodologically, and the molecular weight and molecular weight distribution of 13 batches of samples were determined.
Results: The precision, accuracy, stability, and repeatability tests for SEC-RI-MALLS showed RSD values of 1.35%, 1.58%, 1.53%, and 1.26%, respectively. The SEC-RID method exhibited good linearity (r=0.999 9), with RSD values for precision, accuracy, stability, and repeatability tests (n=6) of 2.05%, 1.62%, 1.30%, and 2.97%, respectively. The results obtained from SEC-RI-MALLS were lower than those from SEC-RID, and the molecular weight distribution coefficient was smaller, but the results from the paired T-test performed with the value measured by SEC-RID method and the value measured by SEC-RI-MALLS method multiplied a conversion coefficient of 1.5 showed no significant difference between the two methods.
Conclusion: Both methods are stable and reliable, and can be used for the determination of PLGA molecular weight and molecular weight distribution based on the specific situations.
- Full text:202503111439197752020250216.pdf
