Determination of molecular weight and distribution of mannatide by means of SEC-RI-MALLS
Objective:To establish a method for determining molecular weight and distribution of raw mannatide and its preparation with SEC-RI-MALLS.Methods:Specificity,accuracy,precision and robustness of SEC-RI-MALLS method was verified by performing on a Shodex OHpak SB-804 HQ column with 0.05 mol·L-1 so-dium sulfate buffer as mobile phase at a flow rate of 0.5 mL·min-1 and a comparison between SEC-RI-MALLS and GPC was studied too.Resulst:The tablet excipient starch had no interference to the test.The rela-tive accuracy error between the measured value and the labeled value of dextran standard was less than 3.0％.RSD of precision was 0.40％when the sample concentration was 2 mg·mL-1 and the RSD of reproducibility and robustness were less than 5.0％.There was no significant difference between Shodex OHpak SB-804 HQ column and TSK-GEL G4000 PWXL column by comparing the results of 79 batches of samples.Compared with the national standard method(GPC)for molecular weight determination,the molecular weight of SEC-RI-MALLS method was 19 509 Da higher on average,and the molecular weight distribution was more concentrated.Conclusion:SEC-RI-MALLS method can determine the molecular weight and distribution of mannatide without standard with good accuracy and robustness.Compared with the existing method,SEC-RI-MALLS method is more conducive to the safety and effectiveness control of the variety.
multi-angle laser light scatteringsize exclusion chromatographygel permeation chromatographymannatidemolecular weight and distribution
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