Acta Scientific Pharmaceutical Sciences (ASPS)(ISSN: 2581-5423)

Research Article Volume 5 Issue 12

Simultaneous Estimation of Gliflozin Derivatives Canagliflozin, Dapagliflozin, Empagliflozin and Ertugliflozin Using RP-HPLC Methods

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

References

  1. Misra M. “SGLT2 inhibitors: a promising new therapeutic option for treatment of type 2 diabetes mellitus”. Journal of Pharmacy and Pharmacology3 (2013): 317-327.
  2. Wright EM and Turk E. “The sodium/glucose co-transport family SLC5”. Pflügers Archiv5 (2014): 510-518.
  3. Harsharan PS., et al. “Sodium Glucose Co-Transporters-2 (SGLT2) Inhibitors as a New Class of Anti-diabetic Drugs: Pharmacokinetics, Efficacy and Clinical Significance”. International Journal of Pharmaceutical Science Review and Research1 (2015): 40-47.
  4. Nair S and Wilding JP. “Sodium glucose co-transporter 2 inhibitors as a new treatment for diabetes mellitus”. Journal of Clinical Endocrinology and Metabolism1 (2010): 34-42.
  5. https://go.drugbank.com/drugs/DB08907
  6. https://go.drugbank.com/drugs/DB06292
  7. https://go.drugbank.com/drugs/DB09038
  8. https://go.drugbank.com/drugs/DB11827
  9. Aris Liakos., et al. “Canagliflozin for Type 2 diabetes: An up-to-date evidence summary”. Diabetes Management2 (2015): 119-125.
  10. Davida Kruger and Virginia Valentine. “Canagliflozin for the Treatment of Diabetic Kidney Disease and Implications for Clinical Practice: A Narrative Review”. Diabetes Therapy 11 (2020): 1237-1250.
  11. Sarah L Anderson “Dapagliflozin efficacy and safety: a perspective review”. Therapeutic Advances in Drug Safety6 (2014) 242-254.
  12. Nareen Krishna Polavarapu., et al. “Dapagliflozin in Clinical Practice - Benefits beyond Glycemic Control. An Expert Review from India”. International Journal of Diabetes1 (2021): 76-90
  13. Ajay chadeve. “A review on pharmacology and therapeutic effects of Empagliflozin in patients with type 2 diabetes mellitus”. Asian Journal of Pharmaceutical and Clinical Research5 (2020): 16-21.
  14. Matthew J Levine. “Empagliflozin for Type 2 Diabetes Mellitus: An Overview of Phase 3 Clinical Trials”. Current Diabetes Review 13 (2017): 405-423.
  15. Vivianne K Nguyen., et al. “Overview of Ertugliflozin”. Clinical Pharmacology Update (2018).
  16. Jie Liu., et al. “Efficacy of Ertugliflozin in monotherapy or combination therapy in patients with type 2 diabetes: A pooled analysis of placebo-controlled studies”. Diabetes and Vascular Disease Research5 (2019): 415-423.
  17. Shahzad Sharif., et al. “Stability Indicating, pH and pKa Dependent HPLC–DAD Method for the Simultaneous Determination of Weakly Ionizable Empagliflozin, Dapagliflozin and Canagliflozin in Pharmaceutical Formulations”. Chromatographia (2020).
  18. Hadir M., et al. “Stability-indicating capillary electrophoresis method for the simultaneous determination of Metformin hydrochloride, Saxagliptin hydrochloride, and Dapagliflozin in pharmaceutical tablets”. Journal of Liquid Chromatography and Related Technologies ISSN 1082-6076 (2019).
  19. Sonia T., et al. “Validated Liquid Chromatographic Method for the Determination of (Canagliflozin, Dapagliflozin or Empagliflozin) and Metformin in the Presence of (1-Cyanoguanidine)”. Journal of Chromatographic Science 1-11 (2018).
  20. Mohini A., et al. “Development and validation of analytical LC-MS method for simultaneous determination of oral hypoglycemic agents (MET, DFZ, EFZ and CFZ) in pharmaceutical dosage form”. World Journal of Pharmaceutical Research6 (2021): 1380-1393.
  21. Bruna Carolina Lui Dias., et al. “A new HPLC–MS/MS method for the simultaneous quantification of SGLT2 inhibitors and Metformin in plasma and its application to a pharmacokinetic study in healthy volunteers”. Biomedical Chromatography 33 (2019): e4663.
  22. ICH guideline Q1A (R2). “Stability testing of new drug substances and products”. ICH (2003).
  23. ICH guideline Q2 (R1). “Validation of Analytical Procedures: Text and Methodology”. ICH (2005).
  24. Murugesan A and Mathrusri Annapurna M. “Validated and quantified stability indicating stress degradation study of oral anti-diabetic agent Canagliflozin by RP-HPLC method”. International Journal of Applied Pharmaceutics5 (2021): 358-363.

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.




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