Journal: Journal of Pharmacy Research

Article Id: JPRS-PC-00001819
Title: Development, corroboration and characterization of genotoxic impurity of 2, 6-dichlorobenzyl chloride in guanfacine hydrochloride by gas chromatography
Category: Pharmaceutical Chemistry
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    Object: This research paper describes a simple analytical method for determination of a genotoxic impurity of 2,6-dichlorobenzyl chloride in Guanfacine hydrochloride drug substance by gas chromatography (GC) method. Methods: It is a non-pharmacopoeia method. Validation was carried out in compliance with the International Conference on Harmonization guidelines. The method utilized GC (Agilent Technologies 6890 N Network GC system with FID detector) and DB-624 capillary column 30 m length × 0.53 mm inner diameter, 3.0 µm film thickness, methyl-phenyl cyanopropyl-polysiloxane as stationary phase. Nitrogen was used as the carrier gas at a flow rate of 4.0 psi with constant pressure mode. The proposed method was validated for linearity, limit of detection, limit of quantitation, accuracy, precision, ruggedness, and solution stability. It can be conveniently adopted for routine quality control analysis.

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    Author(s) Name:

    Suresh Babu. Bodempudi1, 2, Dr. Ravichandra Babu R1*, Dr. Konda Srinivasa Reddy3

    Affiliation(s) Name:

    1 Department of Chemistry, Institute of Science, Gitam University, Visakhapatnam, India

    2 Brundavan Laboratories Private Limited, Hyderabad, India. 3 Dr. Konda’s Life Sciences Private Limited, Hyderabad, India

    *Corresponding author: R. Ravichandra Babu, Department of Chemistry, Institute of Science, Gitam University,Visakhapatnam, Andhra Pradesh, India.

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    Author:

    Suresh Babu. Bodempudi1, 2, Dr. Ravichandra Babu R1*, Dr. Konda Srinivasa Reddy3

    Title:Development, corroboration and characterization of genotoxic impurity of 2, 6-dichlorobenzyl chloride in guanfacine hydrochloride by gas chromatography
    Journal:Journal of Pharmacy Research
    Vol(issue):11(9)
    Year:2017
    Page No: (1105-1111)
  • Experimental Methods Keywords

    Methodology:Gas Chromatography, Genotoxic impurity
    Research Materials:2,6-dichlorobenzyl chloride

Keywords

2 6-dichlorobenzyl chloride Capillary column Gas Chromatography Genotoxic impurity Guanfacine hydrochloride

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