Volume : 09, Issue : 07, July – 2022
29.METHOD DEVELOPMENT AND VALIDATION FOR QUANTIFICATION OF BENZENE AND ETHYLENE DICHLORIDE IN BACLOFEN DRUG SUBSTANCE BY GC-HS USING FID DETECTOR
*Hari Darshan Singh, *Dr. Rahul Kumar
A proficient GC-HS method was developed for quantification of Benzene and Ethylene Dichloride in Baclofen drug substance with flame ionization detector (FID) using column DB-1, (30m length X 0.32mm diameter) 5µm film thickness, Part No.: 123-1035, Make: Agilent. Nitrogen is used as Carrier gas at with flow rate of 1.0 ml/minute. The proposed method was validated for System suitability, Specificity, Linearity, LOD and LOQ determination, Recovery, Precision, Range and Robustness. All the parameters were found within the acceptable limits. Linearity of Benzene and Ethylene Dichloride is in the range of LOQ to 150%. The established methodology was commercially useful, specific, accurate, precise and suitable for the analysis of Benzene and Ethylene Dichloride in Baclofen drug substance.
Keywords: Gas Chromatography with Head space (GC-HS), Guideline for Residual Solvents Q3C(R8) and Method Validation, Baclofen drug substance, Benzene and Ethylene Dichloride
Cite This Article:
Please cite this article in press Hari Darshan Singh et al, Method Development And Validation For Quantification Of Benzene And Ethylene Dichloride In Baclofen Drug Substance By GC-HS Using Fid Detector., Indo Am. J. P. Sci, 2022; 09(7).,
Number of Downloads : 10
1. Parris P, Duncan JN, Fleetwood A, Beierschmitt WP. Calculation of a permitted daily exposure value for the solvent 2-methyltetrahydrofuran. Regul Toxicol Pharmacol 2017;87:54-63.
2. Inoue K, Suzuki H, Yamada T. Comprehensive toxicity evaluation of cyclopentyl methyl ether (CPME) for establishing a permitted daily exposure level. Fundam. Toxicol. Sci. 2019;6:145-65.
3. European Chemicals Agency (ECHA), 2020. Cyclopentyl methyl ether. CASRN 5614-37-9. URL: https://echa.europa.eu/registration-dossier/-/registered-dossier/26626/7/6/2. (last accessed on 15 November 2020)
4. ECHA 2020. Tetrahydro-2-methylfuran. URL: https://www.echa.europa.eu/de/web/guest/registration-dossier/-/registered-dossier/13699/7/9/1. (last accessed 5 November 2020)
5. United States National Toxicology Program (NTP), Toxicology and carcinogenesis studies tert-butyl alcohol (CAS No. 75-65-0), 1995; Number 436; NIH Publication No. 95-3167. URL: https://ntp.niehs.nih.gov/ntp/htdocs/lt_rpts/tr436.pdf. (last accessed 22 December 2020)
6. European Chemicals Agency (ECHA), 2019. 2-Methylpropan-2-ol. CASRN 75-65-0. URL: https://echa.europa.eu/registration-dossier/-/registered-dossier/14112/1. (Last accessed 22 December 2020)
7. ICH Q2 (R1) Validation of Analytical Procedures: Definitions and Methodology, Geneva, 2005, in 2005 incorporated in Q2 (R1).
8. ICH Q3 (R8) Guideline for residual solvents (6 July 2020).
9. ICH M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to limit potential Carcinogenic Risk, Business plan 2010. Position paper 2010.
10. National Library of Medicine, National Center for Biotechnology information Bookshelf ID: NBK526037PMID: 30252293