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建立聚乙二醇干扰素α-2a注射液中游离聚乙二醇含量的HPLC测定方法。以XBridge BEH 300 C4(4.6 mm×15.0 cm,3.5μm)色谱柱为固定相,以水-乙腈为流动相,梯度洗脱,流速1.0 mL/min,蒸发光散射检测器检测。游离聚乙二醇与聚乙二醇干扰素α-2a及其它辅料成分得到很好分离,聚乙二醇在20~100μg/mL范围内,进样量的对数值与峰面积的对数值之间有良好的线性关系(r=0.999),检测限和定量限分别为0.3μg和0.5μg,平均回收率为102.2%(RSD=2.1%)。结果表明,所建立的含量测定方法简便、快速、准确,可用于聚乙二醇干扰素α-2a注射液中游离聚乙二醇的含量测定。
To establish a method for the determination of free polyethylene glycol in peginterferon alfa-2a injection by HPLC. The mobile phase was XBridge BEH 300 C4 (4.6 mm × 15.0 cm, 3.5 μm). The mobile phase consisted of water and acetonitrile with gradient elution at a flow rate of 1.0 mL / min and detected by evaporative light scattering detector. Free polyethylene glycol and pegylated interferon alfa-2a and other accessories ingredients were well separated, polyethylene glycol in the range of 20 ~ 100μg / mL, the logarithm of injection volume and peak area of the logarithmic value (R = 0.999). The limit of detection and limit of quantitation were 0.3μg and 0.5μg respectively. The average recovery was 102.2% (RSD = 2.1%). The results showed that the established assay was simple, rapid and accurate and could be used for the determination of free polyethylene glycol in peginterferon alfa-2a injection.