Determination of Genotoxic Impurity n-acetyl sulfanilic acid methyl ester in Darunavir Drug Substance using RP-HPLC

International Journal of Applied Chemistry

© 2021 by SSRG - IJAC Journal

Volume 8 Issue 3

Year of Publication : 2021

Authors : N.Venkateswara Rao, Dr.V.Siva Ramakrishna, Dr.Ramachandran.D

10.14445/23939133/IJAC-V8I3P103

How to Cite?

N.Venkateswara Rao, Dr.V.Siva Ramakrishna, Dr.Ramachandran.D, "Determination of Genotoxic Impurity n-acetyl sulfanilic acid methyl ester in Darunavir Drug Substance using RP-HPLC," SSRG International Journal of Applied Chemistry, vol. 8,  no. 3, pp. 18-21, 2021. Crossref, https://doi.org/10.14445/23939133/IJAC-V8I3P103

Abstract:

A highly sensitive method for the determination of genotoxic impurities, such as N-acetyl sulfanilic acid methyl ester in Darunavir using RP-HPLC, has been presented in the present paper. Quantification of N-acetyl sulfanilic acid methyl ester content in Darunavir samples by HPLC with UV Detector. The N-acetyl sulfanilic acid methyl ester was determined by RP-HPLC method using Zorbax SB-Phenyl (250 x 4.6mm, 5μm) column as stationary phase. Flow rarely was 0.8 mL/min, Column temperature maintained 30°C, sample cooler temperature 5°C, Injection volume 25μL, and run time was 25mintues. Mobile phase-I was used as milli-Q water, and Mobile phase-B was used as acetonitrile, methanol, and water in the ratio of (80:10:10 v/v/v). The method validation has been carried as per International Conference on Harmonization guidelines (ICH). Limit of quantitation (LOQ) and Limit of detection (LOD) was found 0.374ppm and 0.125ppm for N-acetyl sulfanilic acid methyl ester.

Keywords:

Genotoxic impurity, Darunavir, RP-HPLC method, Validation and Limit of quantitation, and Limit of detection.

References:

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