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Trends in Drug Delivery Original Research

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

  1. Sanjay Nagla Department of Pharmacy, Faculty of Pharmaceutical Science, Mewar University, Gangrar, Chittorgarh
  2. Kamalesh Mistry Department of Pharmacy, Faculty of Pharmaceutical Science, Mewar University, Gangrar, Chittorgarh
  3. Dhananjay Mistry Department of Pharmacy, Faculty of Pharmaceutical Science, Mewar University, Gangrar, Chittorgarh
  4. Shivam Rongpi Department of Pharmacy, Faculty of Pharmaceutical Science, Mewar University, Gangrar, Chittorgarh
  5. Pratyush Kumar Brahma School of Pharmacy, Rai university, SH-144, village - Saroda, taluka - Dholka, Ahmedabad
  6. Mitul Bhoi School of Pharmacy, Rai university, SH-144, village - Saroda, taluka - Dholka, Ahmedabad

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

References (15)

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