实用临床医药杂志2024，Vol.28Issue(17)：92-98,7.DOI:10.7619/jcmp.20241171
高效液相色谱法测定地西泮直肠凝胶有关物质
Determination of related substances in diazepam rectal gel by high-performance liquid chromatography
摘要
Abstract
Objective To establish a high-performance liquid chromatography method for the determination of related substances in diazepam rectal gel.Methods The Agilent ZORBAX Eclipse Plus C18(4.6 mm x 150.0 mm,3.5 μm)column was used with a mobile phase consisting of 10 mmol/L potassium dihydrogen phosphate buffer(adjusted to pH value to 6.0 with 0.5 mmol/L so-dium hydroxide solution)and methanol.Gradient elution was performed at a flow rate of 1.0 mL/min,with a column temperature of 30 ℃ and a detection wave length of 234 nm.Results The chromato-graphic peaks of diazepam and known impurities Ⅰ to Ⅶ showed good resolution.Diazepam and known impurities Ⅰ,Ⅱ,Ⅲ,and Ⅳ exhibited good linearity in the concentrations ranging of 0.01 to 10.05 μg/mL,0.01 to 9.92 μg/mL,0.01 to 10.24 μg/mL,and 0.01 to 10.18 μg/mL,respec-tively(r2 ≥0.999),with average recoveries ranging from 99％to 101％.The excipients in the for-mulation did not interfere with the determination of the principal component and related substances.Conclusion This high-performance liquid chromatography method is highly specific and reproduci-ble,making it suitable for the detection of related substances in diazepam rectal gel.关键词
地西泮/直肠凝胶/杂质/高效液相色谱法/相对校正因子/癫痫Key words
diazepam/rectal gel/impurities/high-performance liquid chromatography/rela-tive correction factor/epilepsy分类
医药卫生引用本文复制引用
徐佳雯,高青,张斐,张雯,王逸..高效液相色谱法测定地西泮直肠凝胶有关物质[J].实用临床医药杂志,2024,28(17):92-98,7.基金项目
江苏省常州市科技计划项目(CJ20220247,CJ20239027) （CJ20220247,CJ20239027）
