Vol. 15 No. 3 (2025): IJCRT, Volume 15, Issue 3, 2025
Articles

Estimation of Benzyl Cyanide as a Genotoxic impurity in Primidone API and its pharmaceutical dosage forms by using GC-FID

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  • Uppalapati Vidyamani,
  • P. Bharat,
  • P.V. Surendra Guptha,
  • Dittakavi Ramachandran,
  • S. Sambamurthy Raju
Uppalapati Vidyamani
Department of Chemistry, Acharya Nagarjuna University, Guntur, Andhra Pradesh, India.
P. Bharat
Department of Chemistry, Acharya Nagarjuna University, Guntur, Andhra Pradesh, India.
P.V. Surendra Guptha
Department of Chemistry, Acharya Nagarjuna University, Guntur, Andhra Pradesh, India.
Dittakavi Ramachandran
Department of Chemistry, Acharya Nagarjuna University, Guntur, Andhra Pradesh, India.
S. Sambamurthy Raju
Department of Chemistry, KVR, KVR & MKR College, Khajipalem, Guntur, Andhra Pradesh, India
DOI: https://doi.org/10.5281/zenodo.15780217

Published 2025-07-01

Keywords

  • Benzyl Cyanide,
  • Primidone,
  • GC-FID,
  • Method Development,
  • Method Validation

How to Cite

Uppalapati Vidyamani, P. Bharat, P.V. Surendra Guptha, Dittakavi Ramachandran, & S. Sambamurthy Raju. (2025). Estimation of Benzyl Cyanide as a Genotoxic impurity in Primidone API and its pharmaceutical dosage forms by using GC-FID. IJCRT Research Journal | UGC Approved and UGC Care Journal | Scopus Indexed Journal Norms, 15(3), 50899–50907. https://doi.org/10.5281/zenodo.15780217

Copyright (c) 2025 IJCRT Research Journal | UGC Approved and UGC Care Journal | Scopus Indexed Journal Norms

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.

Abstract

To develop a Sensitive, accurate, precise and linear GC-FID method for quantitate estimation of Benzyl Cyanide as an impurity in Primidone API at ppm level and validated as per ICH guidelines. This GC-FID method was developed and validated for the trace level analysis of an impurity by using Column: VF-624ms, 30m*0.32mm ID*1.8µm. Carrier Gas: Nitrogen. Flow: 1.0 mL/min. Injector temperature: 200°C. Detector temperature: 250°C. Split ratio: 10. GC Oven program: Initial temperature 100°C hold for 2.0 min and then increase the temperature up to 200°C at Ramp rate 10°C/min hold for 10.0 min and then increase the temperature up to 240°C at Ramp rate 20°C/min hold for 36.0 min. The method was linear for Benzyl Cyanide as an impurity in Primidone 2.5 ppm to 15 ppm respectively. The coefficient of correlation (r) not less than 0.999. The limit of detection and limit of quantification obtained were 0.76 ppm and 2.5 ppm with respect to Sample concentration. The method was fully validated, complying FDA and ICH guidelines and obtained results were within acceptance criteria. The method was successfully validated to determination and quantification of Benzyl Cyanide impurity in Primidone API. Hence, the method holds good for the routine trace analysis of Benzyl Cyanide impurity in Primidone API and its pharmaceutical dosage forms in pharmaceutical industries.

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