Authentication of a Rapid RP-HPLC technique for Quantification of Remogliflozin and Metformin in Medicinal Formulations

Year : 2025 | Volume : 12 | Issue : 02 | Page : 70 77
    By

    Sanjay Nagla,

  • Kamalesh Mistry,

  • Dhananjay Mistry,

  • Shivam Rongpi,

  • Pratyush Kumar Brahma,

  • Mitul Bhoi,

  1. Research Scholar, Department of Pharmacy, Faculty of Pharmaceutical Science, Mewar University, Gangrar, Chittorgarh, Rajasthan, India
  2. Assistant Professor, Department of Pharmacy, Faculty of Pharmaceutical Science, Mewar University, Gangrar, Chittorgarh, Rajasthan, India
  3. Lecturer, Department of Pharmacy, Faculty of Pharmaceutical Science, Mewar University, Gangrar, Chittorgarh, Rajasthan, India
  4. Assistant Professor, Department of Pharmacy, Faculty of Pharmaceutical Science, Mewar University, Gangrar, Chittorgarh, Rajasthan, India
  5. Assistant Professor, School of Pharmacy, Rai university, SH-144, village – Saroda, taluka – Dholka, Ahmedabad, Gujarat, India
  6. Assistant Professor, School of Pharmacy, Rai university, SH-144, village – Saroda, taluka – Dholka, Ahmedabad, Gujarat, India

Abstract

A new, precise, and stability-assessing advanced liquid chromatography (HPLC) technique for simultaneous quantification of Remogliflozin and Metformin in fixed dose pharmaceutical formulations was designed and verified. Optimization of the technique was carried out on flowing phase composed of ethanenitrile and buffer, under isocratic conditions, the resolution of peak being sharp with retention times of 3.24 min and 4.89 min for Remogliflozin and Metformin, respectively. Technology suitability was confirmed by the proportionality across a broad concentration span with correlation coefficient (R²) < 0.999. As per ICH rules, the criteria for validation, including accuracy, precision, robustness and system suitability were found as good %RSD Involvement in robustness studies confirmed the reliability of the method under very small deliberate changes in the analytical conditions. Results of multiple marketed formulations had to meet pharmacopeial limits, proving the method well applicable in routine quality control. Developed HPLC method possesses rapid, sensitive and cost effective concurrent assessment of Remogliflozin and Metformin for bulk and formulation, which may serve as a useful tool for Pharmaceutical Analysis.

Keywords: Remogliflozin, Metformin, HPLC, Method Validation, Pharmaceutical Analysis.

[This article belongs to Trends in Drug Delivery ]

How to cite this article:
Sanjay Nagla, Kamalesh Mistry, Dhananjay Mistry, Shivam Rongpi, Pratyush Kumar Brahma, Mitul Bhoi. Authentication of a Rapid RP-HPLC technique for Quantification of Remogliflozin and Metformin in Medicinal Formulations. Trends in Drug Delivery. 2025; 12(02):70-77.
How to cite this URL:
Sanjay Nagla, Kamalesh Mistry, Dhananjay Mistry, Shivam Rongpi, Pratyush Kumar Brahma, Mitul Bhoi. Authentication of a Rapid RP-HPLC technique for Quantification of Remogliflozin and Metformin in Medicinal Formulations. Trends in Drug Delivery. 2025; 12(02):70-77. Available from: https://journals.stmjournals.com/tdd/article=2025/view=208899


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Regular Issue Subscription Original Research
Volume 12
Issue 02
Received 03/04/2025
Accepted 15/04/2025
Published 26/04/2025
Publication Time 23 Days
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