Research Journal of Pharmacy and Technology

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Applications of Fourier Transform Infrared and Uv-visible Spectroscopy for the Demonstrating Sameness of Ganirelix Peptide in Liquid Injection Formulation


Affiliations
1 Department of Chemistry, Koneru Lakshmaiah Education Foundation, Green Fields, Vaddeswaram, Guntur, Andhra Pradesh – 522502., India
     

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Ganirelix (or Ganirelixum) is a synthetic peptide molecule made up of covalently bonded 10 amino acids. The structural order of peptides determines their biological properties. The minor change in the structure of therapeutic peptides can have a significant impact on their biological behaviors. In this regard, the ganirelix drug product was sterilized at 121°C for 15 mins and further exposed to thermal and humidity at 25°C/60%RH and 40°C/75% RH for 6 months. The ganirelix was isolated using flash chromatography and freeze- dried. We applied Fourier transform infrared (FTIR) and Ultraviolet -Visible (UV-Vis) spectroscopic techniques to investigate temperature and humidity effects on the chemical structure of Ganirelix. FTIR scans were conducted in the wave number range of 4000 – 400cm-1 and UV scans were conducted in the wavelength range of 190 – 400nm. The attained IR stretching vibrations, maximum UV absorbance results, overlayed IR and UV-Vis spectra of Ganirelix in temperature stressed generic drug product is closely comparable to reference listed drug (RLD). In addition, it showed homology in the finger print region of the FTIR with those of the reference listed drug (RLD).

Keywords

Ganirelix acetate, Thermal and humidity effect, Fourier transform infrared (FTIR) spectroscopy, Ultraviolet -Visible (UV-Vis) spectroscopy.
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  • Applications of Fourier Transform Infrared and Uv-visible Spectroscopy for the Demonstrating Sameness of Ganirelix Peptide in Liquid Injection Formulation

Abstract Views: 269  |  PDF Views: 0

Authors

Kumarswamy Ummiti
Department of Chemistry, Koneru Lakshmaiah Education Foundation, Green Fields, Vaddeswaram, Guntur, Andhra Pradesh – 522502., India
J .V. Shanmukha Kumar
Department of Chemistry, Koneru Lakshmaiah Education Foundation, Green Fields, Vaddeswaram, Guntur, Andhra Pradesh – 522502., India

Abstract


Ganirelix (or Ganirelixum) is a synthetic peptide molecule made up of covalently bonded 10 amino acids. The structural order of peptides determines their biological properties. The minor change in the structure of therapeutic peptides can have a significant impact on their biological behaviors. In this regard, the ganirelix drug product was sterilized at 121°C for 15 mins and further exposed to thermal and humidity at 25°C/60%RH and 40°C/75% RH for 6 months. The ganirelix was isolated using flash chromatography and freeze- dried. We applied Fourier transform infrared (FTIR) and Ultraviolet -Visible (UV-Vis) spectroscopic techniques to investigate temperature and humidity effects on the chemical structure of Ganirelix. FTIR scans were conducted in the wave number range of 4000 – 400cm-1 and UV scans were conducted in the wavelength range of 190 – 400nm. The attained IR stretching vibrations, maximum UV absorbance results, overlayed IR and UV-Vis spectra of Ganirelix in temperature stressed generic drug product is closely comparable to reference listed drug (RLD). In addition, it showed homology in the finger print region of the FTIR with those of the reference listed drug (RLD).

Keywords


Ganirelix acetate, Thermal and humidity effect, Fourier transform infrared (FTIR) spectroscopy, Ultraviolet -Visible (UV-Vis) spectroscopy.

References