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

Research Article Volume 6 Issue 1

Novel Simplified Analytical Method for Stress Degradation Study of Empagliflozin an Oral Anti-diabetic Agent by RP-HPLC Method

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 09, 2021

Abstract

The present study involved developing novel, simplified analytical methods for estimating Empagliflozin in API and finished formulation as per the guidelines of ICH. Meanwhile the study focused on conducting forced degradation studies for Empagliflozin to identify the degraded products and its percentage. The applied chromatographic separation method as follows RP-HPLC ZORBAxC18 (250 x 4.6mm, 5μm particle size) with a mobile phase consisting of Acetate buffer: Acetonitrile in a ratio of 60:40% v/v at a flow rate of 1.0 mL/min with an injection volume of 10μl with 6 minutes run time. The Retention time of Empagliflozin was found to be 2.57 ± 0.05min and detected at 232 nm UV wavelength. The method was found to be linear based on the Linear regression equation y = 61309 x- 8123 with correlation coefficient 0.9999. Validation parameters performed as per the prescribed protocol. Stress degradation experiments were performed by exposing the Empagliflozin into acidic, alkaline, oxidative, thermal, and photolytic conditions, withdrawing samples at different time intervals and injected into the system as per ICH guidelines to analyze the drug. The developed method was novel, precise, simple, and accurate with low consumption of organic solvents to estimate Empagliflozin in API and bulk formulation compared to previously reported studies.

Keywords: Empagliflozin; Stress degradation; Validation; ICH; Forced stability; SGLT2; RP-HPL

References

  1. 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.
  2. Misra M. “SGLT2 inhibitors: a promising new therapeutic option for treatment of type 2 diabetes mellitus”. Journal of Pharmacy and Pharmacology3 (2013): 317-327.
  3. 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.
  4. Wright EM and Turk E. “The sodium/glucose co-transport family SLC5”. Pflügers Archiv5 (2014): 510-518.
  5. N Padmaja and G Veerabhadram. “Development and Validation of a Novel Stability-Indicating RP-HPLC Method for the determination of Empagliflozin in Bulk and Pharmaceutical Dosage Form”. International Journal of Pharmaceutical Science and Research11 (2016): 4523-4530.
  6. Mounika P Siridevi., et al. “RP-HPLC Method for Quantification of Empagliflozin in Pharmaceutical Formulation”. Asian Journal of Pharmaceutical Technology3 (2019): 208-211.
  7. Madhurima Basak., et al. “A Rapid and Sensitive RP-HPLC method for the Quantitative Analysis of Empagliflozin in bulk and Pharmaceutical Dosage Form”. International Journal of Applied Pharmaceutics5 (2019): 60-65.
  8. Sushil D., et al. “Development and Validation of Stability Indicating RP-HPLC Method for Empagliflozin”. Asian Journal of Pharmaceutical Analysis 4 (2016): 201-206.
  9. Vinay Kumar D and JVLN Seshagiri Rao. “A New Validated Stability Indicating RP-HPLC Method for Simultaneous Estimation of Metformin Hydrochloride and Empagliflozin in Tablet Dosage Forms”. International Research Journal of Pharmacy and Medical Sciences5 (2018): 16-22.
  10. Syed Irfan Ali and Bharath Rathna Kumar P. “Stability Indicating Simultaneous Estimation of Metformin and Empagliflozin in Pharmaceutical Tablet Dosage form by RP-HPLC”. Asian Journal of Research in Chemistry6 (2017): 783-788.
  11. Nachiket S Dighe., et al. “Simultaneous Estimation, Validation and Force Degradation Study of Metformin Hydrochloride and Empagliflozin by RP-HPLC Method”. Research Journal of Science and Technology2 (2019): 135-147.
  12. Sharmila Donepudi and Suneetha Achanta. “Validated HPLC-UV method for simultaneous estimation of Linagliptin and Empagliflozin in human plasma”. International Journal of Applied Pharmaceutics3 (2018): 56-61.
  13. Nagunath Sirigiri., et al. “Stability indicating method development and validation for simultaneous Estimation of Linagliptin and Empagliflozin in tablets by HPLC”. Saudi Journal of Medical and Pharmaceutical Sciences8 (2018): 884-896.
  14. Wael Abu Dayyih., et al. “Development and Validation of a Stability-Indicating HPLC Method for Empagliflozin and Linagliptin in Tablet Dosage Form”. Asian Journal of Chemistry2 (2021): 484-488.
  15. T Naga Ravi Kiran., et al. “Development and Validation of RP-HPLC Method for the Simultaneous Estimation of Linagliptin, Empagliflozin and Metformin in Solid Dosage Forms”. Asian Journal of Pharmaceutical Analysis3 (2020): 117-124.
  16. RP Bhole., et al. “Stability Indicating HPTLC Method for Simultaneous Estimation of Empagliflozin and Linagliptin in Pharmaceutical Formulation”. Analytical Chemistry Letters1 (2017): 76-85.
  17. Bassam M Ayoub and Shereen Mowaka. “LC-MS/MS Determination of Empagliflozin and Metformin”. Journal of Chromatographic Science7 (2017): 742-747.
  18. Mohamed Rizk., et al. “Thermo analytical study and purity determination of Anti-diabetic drugs Linagliptin and Empagliflozin in drug substances”. Chemistry Research Journal4 (2020): 6-20.
  19. Shaik Bima Benazir., et al. “Method Development and Validation of Empagliflozin in Bulk and Pharmaceutical Dosage Form using UV Spectroscopy”. Asian Journal of Pharmaceutical Analysis2 (2021): 123-126.
  20. Sushil D Patil., et al. “Development and Validation of Simple UV- Spectrophotometric Method for the Determination of Empagliflozin”. Asian Journal of Pharmaceutical Analysis1 (2017): 18-22.
  21. Sushil D Patil., et al. “Development and validation of UV spectrophotometric method for Simultaneous estimation of Empagliflozin and Metformin hydrochloride in bulk drugs”. Asian Journal of Pharmaceutical Analysis2 (2017): 117-123.
  22. Sushil D Patil., et al. “Spectrophotometric simultaneous determination of Empagliflozin and Metformin in combined tablet dosage form by absorbance corrected method, area under curve method, and dual wavelength spectrophotometry”. Asian Journal of Research in Chemistry 12 .2 (2019): 94-98.
  23. Manojkumar K., et al. “Development and Validation of Novel Analytical Method for Empagliflozin and Metformin Hydrochloride in Bulk and Pharmaceutical Dosage Form by Four Different Simultaneous Estimation Approaches using UV Spectroscopy”. Research Journal of Pharmacy and Technology3 (2020): 1236-1242.
  24. Mokhtar M Mabrouk., et al. “Ultrasound-assisted dispersive liquid-liquid microextraction for determination of three gliflozins in human plasma by HPLC/DAD”. Journal of Chromatography B 1136 (2019): 121932.
  25. ICH guideline Q1A (R2). “Stability testing of new drug substances and products”. ICH (2003).
  26. ICH guideline Q2 (R1). “Validation of Analytical Procedures: Text and Methodology”. ICH (2005).

Citation

Citation: Arulselvan Murugesan and Annapurna Mukthinuthalapati Mathrusri. “Novel Simplified Analytical Method for Stress Degradation Study of Empagliflozin an Oral Anti-diabetic Agent by RP-HPLC Method". Acta Scientific Pharmaceutical Sciences 6.1 (2022): 59-66.

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.




Metrics

Acceptance rate32%
Acceptance to publication20-30 days

Indexed In




News and Events


  • Certification for Review
    Acta Scientific certifies the Editors/reviewers for their review done towards the assigned articles of the respective journals.
  • Submission Timeline for Upcoming Issue
    The last date for submission of articles for regular Issues is December 15, 2022.
  • Publication Certificate
    Authors will be issued a "Publication Certificate" as a mark of appreciation for publishing their work.
  • Best Article of the Issue
    The Editors will elect one Best Article after each issue release. The authors of this article will be provided with a certificate of “Best Article of the Issue”.
  • Welcoming Article Submission
    Acta Scientific delightfully welcomes active researchers for submission of articles towards the upcoming issue of respective journals.
  • Contact US