IDENTIFICATION OF RESIDUAL SOLVENTS BY USING GC – HS METHOD FOR EZETIMIBE
DOI:
https://doi.org/10.48047/7k56dr07Keywords:
GC – HS, Ezetimibe drug, Residual Solvents – Methanol, Acetone, IPA, DCM, n – Hexane, DMF, Toluene, Ethyl Acetate, THFAbstract
A Simple, Specific, sensitive, accurate, robust, precise GC -HS Method was developed
and validated for stability indicating analytical method development and validation for identification
of residual solvents for Ezetimibe drug. The method was developed by using DMSO (Dimethyl
Sulphoxide) as a mobile phase. The Column used for separation was ZB-624 with dimensions as 30m x
0.53mm, 3.0 µm thickness with flow rate 2.0ml/min and Injector temperature is 2000
c and 260 0
c
detector temperature with the split ratio is 1:5 and with run time 25 min and constant flow 2.0 ml/min.
The validation was carried out on the optimised method and the obtained results were within the limits
of acceptance criteria for parameters like System suitability, Specificity, Linearity, Accuracy,
Precision, LOD, LOQ, Robustness and the stability of the method has been checked by solution
stability studies. Based on the above information the method can be used for daily routine analysis.
Downloads
Downloads
Published
Issue
Section
License
This work is licensed under a Creative Commons Attribution 4.0 International License.
You are free to:
- Share — copy and redistribute the material in any medium or format for any purpose, even commercially.
- Adapt — remix, transform, and build upon the material for any purpose, even commercially.
- The licensor cannot revoke these freedoms as long as you follow the license terms.
Under the following terms:
- Attribution — You must give appropriate credit , provide a link to the license, and indicate if changes were made . You may do so in any reasonable manner, but not in any way that suggests the licensor endorses you or your use.
- No additional restrictions — You may not apply legal terms or technological measures that legally restrict others from doing anything the license permits.
Notices:
You do not have to comply with the license for elements of the material in the public domain or where your use is permitted by an applicable exception or limitation .
No warranties are given. The license may not give you all of the permissions necessary for your intended use. For example, other rights such as publicity, privacy, or moral rights may limit how you use the material.
