丙泊酚甲磷酸钠盐的含量测定及其杂质检查

Content determination of propofol methyl disodium salt and the examination of propofol

目的 建立测定原料药丙泊酚甲磷酸钠的含量及检查杂质的方法。方法 采用HPLC法和酸碱滴定法。结果 丙泊酚甲磷酸钠盐在0．82～4．04μg范围内，线性关系良好（r=0．9998），日内及日间精密度分别为0．26％、0．32％；丙泊酚检查的定量限为0．016ng（S／N=10），在6．73～323．4ng范围内，线性关系良好（r=0．9991）。结论 所建立的方法简便、灵敏、准确，可用于丙泊酚甲磷酸钠的含量测定及杂质丙泊酚的检查。

OBJECTIVE To develop a method for determining the contents in propofol methyl disodium salt and the examination of propofol. METHODS Ion - pair RP - HPLC and acid - base titration were adopted to determine the contents in propofol methyl disodium salt and RP - HPLC was adopted for the examination of propofol. RESULTS Ion - pair RP - HPLC method to determine the contents in propofol methyl disodium salt had good linearity in the range of 0.82 - 4.04 μg（ r = 0. 9998 ）. In the examination of propofol, the calibration curve was linear in the range of 6.73 - 323.4 ng（ r = 0. 9991 ） , and the quantitation limit was 0. 016 ng （ S/N = 10）. CONCLUSION These methods are simple,sensitive and practicable for the assay of propofol methyl disodium salt and examination of propofol.