HPLC测定吗替麦考酚酯口服混悬剂(骁悉)中尼泊金甲酯含量

Determination of Methylparaben in Mycophenolate Mofetil for Oral Suspension(CellCept)by HPLC

建立了一种测定吗替麦考酚酯口服混悬剂中尼泊金甲酯含量的方法。采用高效液相色谱法,色谱柱:YMC-Pack Pro C18(150 mm×4.6 nm,5μm);流动相:甲醇-1%乙酸水(60∶40);检测波长:254 nm;流速:0.7 mL·min^(-1);柱温:30℃;进样量:10μL。采用该法测定,专属性强,精密度好(RSD=1.16%,n=12),准确度高(平均加样回收率为99.35%,回收率RSD<2%),操作简单,适用吗替麦考酚酯混悬剂生产中尼泊金甲酯含量检测。该法测得的吗替麦考酚酯混悬液中尼泊金甲酯含量为3.18 mg·mL^(-1),占混悬剂质量的0.50%。

To establish a method for the determination of methylparaben in mycophenolate mofetil for oral suspension.HPLC column:YMC-Pack Pro C18 column(150 mm×4.6 nm,5μm);mobile phase:methanol-1%acetic acid water(60∶40);detection wavelength:254 nm;flow rate:0.7 mL•min^(-1);column temperature:30℃;the sample volume:10μL.The method has strong specificity,good precision(RSD=1.16%,n=12),high accuracy(average recovery of 99.35%,recovery RSD<2%),simple operation,and is applicable to the detection of methylparaben in the production of mycophenolate mofetil for oral suspension.The content of methylparaben in the suspension measured by this method was 3.18 mg•mL^(-1),accounting for 0.50%of the suspension.