摘要
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.
出处
《华西药学杂志》
CAS
CSCD
北大核心
2007年第1期74-76,共3页
West China Journal of Pharmaceutical Sciences