Determination of related substances in diazepam rectal gel by high-performance liquid chromatography

XU Jiawen; GAO Qing; ZHANG Fei; ZHANG Wen; WANG Yi

doi:10.7619/jcmp.20241171

Journal of Clinical Medicine in Practice > 2024 > 28(17): 92-98. > DOI: 10.7619/jcmp.20241171

XU Jiawen, GAO Qing, ZHANG Fei, ZHANG Wen, WANG Yi. Determination of related substances in diazepam rectal gel by high-performance liquid chromatography[J]. Journal of Clinical Medicine in Practice, 2024, 28(17): 92-98. DOI: 10.7619/jcmp.20241171

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Determination of related substances in diazepam rectal gel by high-performance liquid chromatography

1.
Department of Pharmacy, Changzhou Maternal and Child Health Care Hospital of Changzhou Medical Center of Nanjing Medical University, Changzhou, Jiangsu, 213000
2.
Analytical Department, Jiangsu Foursea Pharmaceutical Technology Co., Ltd., Nanjing, Jiangsu, 210000

More Information

Received Date: March 19, 2024
Revised Date: May 09, 2024

Graphical Abstract

Abstract

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×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 sodium 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 chromatographic 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, respectively (r²≥0.999), with average recoveries ranging from 99% to 101%. The excipients in the formulation did not interfere with the determination of the principal component and related substances.
Conclusion
This high-performance liquid chromatography method is highly specific and reproducible, making it suitable for the detection of related substances in diazepam rectal gel.
- diazepam,
- rectal gel,
- impurities,
- high-performance liquid chromatography,
- relative correction factor,
- epilepsy

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References (17)

References

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Determination of related substances in diazepam rectal gel by high-performance liquid chromatography