Determination of related substances in diazepam rectal gel by high-performance liquid chromatography
- VernacularTitle:高效液相色谱法测定地西泮直肠凝胶有关物质
- Author:
Jiawen XU
1
;
Qing GAO
;
Fei ZHANG
;
Wen ZHANG
;
Yi WANG
Author Information
- Keywords: diazepam; rectal gel; impurities; high-performance liquid chromatography; rela-tive correction factor; epilepsy
- From: Journal of Clinical Medicine in Practice 2024;28(17):92-98
- CountryChina
- Language:Chinese
- 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.
