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小分子肽类制剂多采用反相高效液相色谱法(RPLC)进行质量控制。本文采取最优化的C_(18)反相色谱系统,以梯度洗脱法对催产素、脱氨催产素等质量控制的精密度、方法的选择性和变异性进行了讨论。浓度范围1～200IUml~(-1),相当于2～400μgml~(-1)。催产素色谱条件流动相A:50%乙腈;B:0.1 mol/LNaH_2PO_4 柱RP-C_(18)5μm125×4.6mm 梯度30%A～60%A(30′) 流速每分钟1 ml 注射容量最大至200μl 温度室温检测器UV220nm 其它九肽类色谱条件流动相A:0.02 mol/L氢氧化四甲基
More small peptide preparations using reverse phase high performance liquid chromatography (RPLC) for quality control. In this paper, the optimized C_ (18) reversed-phase chromatography system was used to analyze the precision, the selectivity and the variability of the methods of quality control such as oxytocin and deamination oxytocin by gradient elution. Concentration range of 1 ~ 200IUml ~ (-1), equivalent to 2 ~ 400μgml ~ (-1). Oxytocin Chromatography Conditions Mobile phase A: 50% acetonitrile; B: 0.1 mol / L NaH2PO4 column RP-C18 5 μm 125 4.6 mm gradient 30% A to 60% A (30 ’) Flow rate 1 ml per minute Injection volume up to 200 μl Temperature Room Temperature Detector UV220 nm Other Nonapeptides Chromatographic Conditions Mobile phase A: 0.02 mol / L Tetramethylhydroxide