Comparison of related substances of protamine recombinant human insulin injection at home and abroad
Objective Protamine recombinant human insulin injection is suitable for the treatment of type 2 diabetes patients,and the current standard only controls the content of A21 desamido human insulin which is related to the product,but does not control the content of B3 and B3iso desamido human insulin.To determine the related substances in 17 batches of protamine recombinant human insulin injection by two methods,and compare the quality at home and abroad.Methods An HPLC method was used with a Waters Xbridge C18 column 250 mm×4.6 mm(5 μm).The detection wavelength was 214 nm,the column temperature was 30℃,the flow rate was 1.0 ml/min and the injection volume was 20 μl.The mobile phase A of Chinese Pharmacopoeia 2020 edition was 0.2 mol/L sodium sulfate solution(pH 2.3)-acetonitrile(82∶18),mobile phase B was acetonitrile-water(50∶50)with gradient elution.The mobile phase A of enterprise self-designed method was 0.2 mol/L sodium sulfate solution(pH 3.6)-acetonitrile(90∶10),mobile phase B was acetonitrile-water(50:50)with gradient elution.Results There was no significant difference in the content of A21 desamido human insulin at home and abroad,the content of B3 and B3iso desamido human insulin in one domestic enterprise was lower than that of other enterprises,and the total amount of related substances in another domestic enterprise was higher than that of other enterprises.There was no significant difference in the content of A21 desamido human insulin detected by the two methods(P＞0.05),and more related substances can be detected by the enterprise self-designed method.Conclusion Both methods are fast and simple,and can be used to compare the related substances in domestic and foreign samples,and provide a basis for enterprises to establish impurity control limits.
Protamine recombinant human insulinPremixed 30RA21 desamido human insulinB3 desamido human insulinB3iso desamido human insulin
万方数据
维普
