Determination of 3-Chloro-1,2-Propanediol content in Iohexol drug substance by using High-Performance Liquid Chromatography with refractive index detector

International Journal of Applied Chemistry

© 2020 by SSRG - IJAC Journal

Volume 7 Issue 3

Year of Publication : 2020

Authors : Sanni Babu Najana, Hari Babu Bollikolla

10.14445/23939133/IJAC-V7I3P111

How to Cite?

Sanni Babu Najana, Hari Babu Bollikolla, "Determination of 3-Chloro-1,2-Propanediol content in Iohexol drug substance by using High-Performance Liquid Chromatography with refractive index detector," SSRG International Journal of Applied Chemistry, vol. 7,  no. 3, pp. 57-64, 2020. Crossref, https://doi.org/10.14445/23939133/IJAC-V7I3P111

Abstract:

A highly sensitive method for determining impurity, such as 3-Chloro-1,2-propanediol in Iohexol drug substance using RP-LC, has been presented in the present paper. Quantification of 3-Chloro-1,2-propanediol content in Iohexol samples by HPLC with Refractive Index (RI) Detector. The separation, detection, and quantification of 3-Chloro-1,2-propanediol were determined using Symmetry shield reverse phase C18 (250x4.6mm, 5μm) column as the stationary phase. Column temperature maintained 25°C, Injection volume 30μL, and the Flow rate was 0.6 ml/min, sample cooler temperature ambient, and RID temperature 30°C. pH 4.65 phosphate buffer was used as the mobile phase. The method validation has been carried as per International Conference on Harmonization guidelines. The limit of quantitation (LOQ) was found 1.29 ppm for 3-Chloro-1,2-propanediol.

Keywords:

3-Chloro-1,2-propanediol, Iohexol, Refractive index detector, validation, and limit of quantitation

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