Arulselvan Murugesan¹* and Annapurna Mukthinuthalapati Mathrusri²

¹Department of Pharmaceutical Analysis, AIKTC School of Pharmacy, New Panvel Dist-Raigad (M.S.), India
²Department of Pharmaceutical Analysis and Quality Assurance, GITAM Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, India

*Corresponding Author: Arulselvan Murugesan, Department of Pharmaceutical Analysis, AIKTC School of Pharmacy, New Panvel Dist-Raigad (M.S.), India.

Received: September 21, 2021; Published: December 07, 2021

Abstract

A reliable, simple, precise, stability indicating reverse phase HPLC method was developed to study simultaneous estimation of Gliflozin derivatives like Canagliflozin, Dapagliflozin, Empagliflozin and Ertugliflozin. Focus of our study is to quantify the derivatives with freely available non expensive solvent systems within a short period of time. The chromatographic separation obtained by using Inertsil ODS column (25 cm x 46 mm) x 5 µm internal diameter with isocratic flow. The mobile phase TEA: ACN pH (50:50) at a flow rate 1 ml/min. The analytes were detected by using a UV detector at 260 nm. Forced degradation studies for gliflozin derivatives conducted as per the ICH guidelines and the resulting degrades were characterized by its peak area at its retention time as per the proposed method. The system suitability results support the proposed method elutes the analytes with good resolution within 10 min in a repeatable manner. The linearity value observed with the concentration range of 30-450 µg/mL for Canagliflozin, 1-15 µg/mL for Dapagliflozin, 2.5 to 37.50 µg/mL for Empagliflozin and 0.5 to 7.5 µg/mL for Ertugliflozin and its calibration curve value found to be y = 25151x + 40130 (r² = 0.9991), y = 109655x +8166 (r² = 0.9989), y = 73755x + 636 (r² = 0.9998), y = 169230x + 8269 (r² = 0.9997) respectively. The percentage recovery of the drugs found to be 100.2-100.4, 99.7-100.6, 99.5-99.7, 99.6-100.03 for 50%, 100% and 150% and these results are within acceptable limits. In this developed method the separated analyte peak found to be sharp, specific, reproducible, and robust in all the studies conducted in repeatable process. Forced degradation studies involved in studying the drug stability in different stress conditions and to identify the degradants of the drug products. The validated method found precise in forced degradation studies conditions and found less than 10% degradation products in this study. The developed and validated method proved that the proposed method was simple, reliable, highly specific and stability indicating for gliflozin derivatives based on its statistical data obtained with its peak area and relevant factors. Hence, this method might be applied for simultaneous estimation of all these drugs in pharmaceutical formulation.

Keywords: Canagliflozin; SGLT2; T2DM; Dapagliflozin; Empagliflozin; Ertugliflozin; RP HPLC; Forced Degradation

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Citation

Citation: Arulselvan Murugesan and Annapurna Mukthinuthalapati Mathrusri. “Simultaneous Estimation of Gliflozin Derivatives Canagliflozin, Dapagliflozin, Empagliflozin and Ertugliflozin Using RP-HPLC Methods". Acta Scientific Pharmaceutical Sciences 6.1 (2022): 03-12.

Copyright

Copyright: © 2022 Arulselvan Murugesan and Annapurna Mukthinuthalapati Mathrusri.> This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.