【摘要】 采用高效液相色谱法测定了药用辅料聚L乳酸中乳酸单体的残留量。采用正交试验优化了色谱的条件,以甲醇-0.1mol.L磷酸二氢钾(5+95)混合液为流动相,流量为0.8mL.min-1,柱温为40℃。乳酸的质量浓度在2.00～100mg·L-1范围内与其峰高呈线性关系,方法的检出限(3S/N)为0.50mg·L-1。对方法进行了回收率和精密度试验,样品的加标平均回收率为96%;测定值的相对标准偏差(n=6)为2.0%。更多还原

【Abstract】 HPLC was applied to the determination of residual amount of lactic acid monomer in the pharmaceutical adjuvant poly L-lactic acid.The optimized chromatographic conditions obtained by orthogonal test were as follow: a mixture of methanol and 0.1 mol·L-1 KH2PO4 solution,mixed in the ratio of 5 to 95 was used as mobile phase,with a flow-rate of 0.8 mL·min-1 and at the column temperature of 40 ℃.Linear relationship between values of peak height and mass concentration of lactic acid was kept in the range of 2.00-100 mg·L-1,with detection limit(3S/N) of 0.50 mg·L-1.Tests for recovery and precision were made,giving results of average recovery of 96% and RSD(n=6) of 2.0% respectively.更多还原