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| Charge Variants Determination of Anti-EGFR Antibody by Capillary Zone Electrophoresis |
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| DOI： |
| KeyWord:capillary zone electrophoresis charge variants anti-EGFR antibody additives |
| Author | Institution |
| KE Zhi，ZHOU Dong-mei，XU Jun，SUEN Wen-chen，YANG Bin* |
广东东阳光药业有限公司 |
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| Abstract: |
| A simple and rapid capillary zone electrophoresis method was developed for charge variants determination of anti-epidermal growth factor receptor(EGFR) antibody.To obtain better resolution of antibody charge variants and less analysis time，a number of separation parameters were investigated，including concentration and pH value of separation buffer，concentration of additives，separation voltage and temperature of capillary.The optimized conditions were as follows: separation buffer:pH 6.0 380 mmol?L-1 6-aminocaproic acid(EACA) containing 0.1% hydroxypropyl methyl cellulose(HPMC) and 1.9 mmol?L-1 triethylenetetramine(TETA)；applied separation voltage:25 kV；capillary temperature: 20 ℃.Under the optimized conditions，the highest resolution was obtained among all the charge variants in 8 min.Meanwhile，all the components，including the main component，acidic variants，basic variants 1 and basic variants 2，were linear in the range of 0.1-1 mg?mL-1 with correlation coefficients more than 0.99.The limit of quantitation for the four charge variants were 30.0，150.2，125.2 ,93.3 μg?L-1，respectively.The method showed a good repeatability and intermediate precision for all components with RSDs less than 2%，and the recoveries for all the antibody charge variants ranged from 95.4% to 105.4%.This method was simple，rapid and low cost，and could meet the requirement for the determination the charge variants of anti-EGFR antibody. |
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