|
Analytical Method Validation For The Determination Of Residual Solvents And Limit Of Chloromethyl Isopropyl Carbonate In Tenofovir Disoproxil Orotate By Gc-Hs.
|
|
| Author:
|
J.NAGESWARA RAO, CH.SUDHAKAR
|
| Abstract:
|
The present study of research aims to develop and optimize an accurate and precise Headspace gas chromatography (HSGC) method for the determination of residual solvents (Ethanol, Acetone, Isopropyl alcohol, Dichloromethane, t-Butanol, Ethyl acetate, Cyclohexane, Toluene) and Chloromethyl isopropyl carbonate in Tenofovir disoproxil orotate using DB-624, 30 m x 0.32 mm x 1.8 µm as stationary phase. Tenofovir disoproxil orotate is thermally stable compound and maintained the temperature of 200°c and 270°c at inject port and detector respectively. Nitrogen gas has been used as mobile phase with a flow rate of 0.5 ml/minute and detected by FID. The hydrogen and zero air rate of flow at 30ml/min and 300ml/min were maintained respectively. The diluent used is N-methyl-2-pyrrolidone85% and Water15% v/v. All solvents were well resolved each other with diluents peak. The total run time 42.5 minutes and retention times were observed for the residual solvents such as Ethanol, Acetone, Isopropyl alcohol, Dichloromethane, t-Butanol, Ethyl acetate, Cyclohexane, Toluene, and Chloromethyl isopropyl Carbonate are 9.87, 11.46, 11.99, 13.44, 13.87, 18.89, 20.32, 25.18 and 29.33 respectively. The method was validated and met all the regulations of system suitability, specificity, method precision, linearity, limit of detection, limit of quantization, precision of LOQ, and accuracy (recovery) under ICH guidelines specification.
|
| Keyword:
|
Headspace-gas chromatography, Tenofovir Disoproxil orotate, Method validation, Residual solvents.
|
| EOI:
|
-
|
| DOI:
|
https://doi.org/10.31838/ijpr/2021.13.03.125
|
| Download:
|
Request For Article
|
|
|