A novel RP- HPLC method development and forced degradation studies for semaglutide in active pharmaceutical ingredients and pharmaceutical dosage form

  • Arun Kumar Kuna Department of Pharmaceutical Analysis, Gitam Institute of Pharmacy, Gitam University (Deemed to be University) Rushikonda, Visakhapatnam- 530 045, Andhra Pradesh, India
  • Ganapaty S Department of Pharmaceutical Analysis, Gitam Institute of Pharmacy, Gitam University (Deemed to be University) Rushikonda, Visakhapatnam- 530 045, Andhra Pradesh, India
  • Radha GV Department of Pharmaceutical Analysis, Gitam Institute of Pharmacy, Gitam University (Deemed to be University) Rushikonda, Visakhapatnam- 530 045, Andhra Pradesh, India

Abstract

This research objective is for the development of a specific and simple method to trace Semaglutide presence in active pharmaceutical ingredient and pharmaceutical dosages. As part of a study on Semaglutide drug, solvents of HPLC grade waters HPLC instrument (Empower software) with PDA detector, ultrasonicator (Make: Labman) and pH meter (Make: Adwa) are used. The Method was optimized with mobile phase with a composition of buffer and solvent were of 60:40%v/v, flow maintained was 1.0ml/min, the injection volume of 10µl, run time was 5min. All separations were performed with PDA detector and column used was Discovery C18 150 x 4.6mm, 5m. Results for the developed method are accurate and specific. The detection wavelength was 292 nm, the retention time for Semaglutide was 2.689min, linearity resulted with r2= 0.9998, % RSD for precision was 1.0; %mean recovery for accuracy was in the range of 99.73 to 100.29.  This study report is for industrial application for determining Semaglutide presence in pharmaceutical ingredient and dosages.

Keywords: Semaglutide, RP-HPLC, Validation, Method Development, Detection

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Published
2019-04-15
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How to Cite
Arun Kumar Kuna, Ganapaty S, & Radha GV. (2019). A novel RP- HPLC method development and forced degradation studies for semaglutide in active pharmaceutical ingredients and pharmaceutical dosage form. International Journal of Research in Pharmaceutical Sciences, 10(2), 865-873. https://doi.org/10.26452/ijrps.v10i2.263
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Original Articles
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