Arulselvan Murugesan¹* and Annapurna Mukthinuthalapati Mathrusri²

¹Department of Pharmaceutical Analysis, AIKTC School of Pharmacy, 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, India.

Received: September 21, 2021; Published: November 10, 2021

Abstract

Precise, simple and Stability indicating RP-HPLC method was developed and validated for Ertugliflozin in this study. Major objective of this proposed method for Ertugliflozin validated as per the guidelines of ICH and FDA. The following parameters were validated according to ICH guidelines in terms of System suitability, Solution stability, Linearity, Accuracy, Precision, Robustness and Stress degradation studies. In this proposed method, the separation was carried out using C18 Hypersil ODS Column (250 mm x 4.6 mm, 5 µm) with isocratic flow and the mobile phase utilized was acetate buffer and acetonitrile 60:40 (v/v). Ertugliflozin peaks were identified and separated at UV detection wavelength 240 nm. The pH of acetate buffer was adjusted to 4.0 with O-Phosphoric acid. The retention time for Ertugliflozin was found to be 2.30 ± 0.04 min. The results were found linear with concentration range 2.5 to 50 µg/ml (r2 = 0.9998). The % recovery for the developed method found 98.48 to 99.43% for Accuracy and Precise for Intra and Interday method. No deliberate variation found for our developed method in flow rate, mobile phase and detection wavelength. The precision report for various concentrations (5 µg/ml, 7.5 µg/ml and 10µg/ml) found to be less than 2% for Intra and Interday precision. In forced degradation studies, Ertugliflozin was stable in Acidic, Alkaline, Thermal conditions whereas in Photolytic and oxidative conditions notable degradation was observed. The RP-HPLC method was validated according to ICH and FDA guidelines. The developed method was found to be Specific, precise, simple, sensitive, accurate, linear and thus to be considered stability indicating for Ertugliflozin pharmaceutical formulations and research tablets.

Keywords: Ertugliflozin; RP-HPLC; Stability Indicating; T2DM; SGLT2; ICH; USFDA

References

1. Leonor Guariguata., et al. “IDF Diabetes Atlas”. International Diabetes Federation (2013).
2. Chaudhury Arun., et al. “Clinical Review of Antidiabetic Drugs: Implications for Type 2 Diabetes Mellitus Management”. Frontiers in Endocrinology 8 (2017): 6.
3. Ertugliflozin - DrugBank (2020).
4. Miao Z., et al. “Pharmacokinetics, metabolism, and excretion of the antidiabetic agent Ertugliflozin (PF-04971729) in healthy male subjects. Drug Metabolism and Disposition: the biological fate of chemicals”. 41.2 (2013): 445-456.
5. Cinti F., et al. “Spotlight on Ertugliflozin and its potential in the treatment of type 2 diabetes: evidence to date”. Drug Design, Development and Therapy 11 (2017): 2905-2919.
6. China Babu D., et al. “A new stress indicating RP-HPLC method development and validation for the simultaneous estimation of Ertugliflozin and Metformin in bulk and its tablet dosage form”. Oriental Journal of Chemistry. Indian Drugs2 (2019): 39-46.
7. Tahir Nizami BS and PS. "Analytical method development and validation for simultaneous estimation of Ertugliflozin and Metformin in tablet dosage form by RP-HPLC". International Journal of Pharmacy and Life Science. Journal of Global Pharma Technology 10 (2018): 6-14.
8. Rao P V., et al. “Development and Validation of New Stability Indicating Reversed-Phase High-Performance Liquid Chromatography Method for Simultaneous Determination of Metformin Hydrochloride and Ertugliflozin in Bulk and Pharmaceutical Dosage Form”. Asian journal of Pharmaceutical and Clinical Research1 (2019): 235.
9. Rao AL and Krishnaveni U. "Stability Indicating RP-HPLC Method for Simultaneous Estimation of Metformin and Ertugliflozin". Journal of Pharmaceutical and Medicinal Chemistry2 (2019): 1-9.
10. Syed Wajahat Shafaat., et al. “Analytical method development and validation for simultaneous estimation of Ertugliflozin and Metformin HCl in bulk and pharmaceutical dosage form by HPLC". Journal of Chemical Information and Model9 (2019): 1689-99.
11. Anjali M., et al. “Method Development and Validation of Ertugliflozin and Sitagliptin by Using Simultaneous Equation Method". Journal of Innovative Pharmaceutical Science1 (2019): 22-28.
12. M Laxmi., et al. “RP-HPLC Method Development and Validation for Simultaneous Estimation of Ertugliflozin and Sitagliptin in Bulk and Tablet Dosage Forms”. Indian Journal of Applied Research10 (2019): 9-13.
13. Amtul Hadi Hadiya and Mohammad Yunoos. “A new validated stability indicating RP-HPLC method for the simultaneous estimation of Sitagliptin and Ertugliflozin in bulk drug and formulation". Indo American Journal of Pharmaceutical Sciences 09 (2018): 8785-8794.
14. P Venkateswara Rao., et al. “Simultaneous estimation of Ertugliflozin and Sitagliptin in bulk and pharmaceutical dosage form its validation parameters as per ICH guidelines". Indo American journal of Pharmaceutical Sciences 4 (2018): 2616-27.
15. Harshalatha P., et al. “A novel RP-HPLC method for simultaneous determination of Ertugliflozin and Sitagliptin in bulk and tablet dosage form”. International Journal of Research in Pharmaceutical Sciences 3 (2018): 1042-1050.
16. D China Babu., et al. “Novel Stress Indicating RP-HPLC Method Development and Validation for the Simultaneous Estimation of Ertugliflozin and Sitagliptin in Bulk and its Formulation”. Oriental Journal of Chemistry5 (2018): 2554-2561.
17. Qiu X., et al. “UPLC-MS/MS method for the quantification of Ertugliflozin and Sitagliptin in rat plasma". Analytical Biochemistry 567 (2019): 112-116.
18. Sahasrabudhe V., et al. “Effect of Food on the Pharmacokinetics of Ertugliflozin and Its Fixed-Dose Combinations Ertugliflozin/Sitagliptin and Ertugliflozin/Metformin”. International Journal of Pharmaceutical Science and Research. Clinical Pharmacology in Drug Development5 (2019): 619-627.
19. Suleman S Khoja and Laxman J Patel. “Development and Validation of New Analytical LCMS/MS Method for the Estimation of Antidiabetic Drugs Ertugliflozin and Sitagliptin in Combined Pharmaceutical Dosage form”. Journal of Pharmaceutical Research International30A (2021): 194-204.
20. Han DG., et al. “A novel high-performance liquid chromatographic method combined with fluorescence detection for determination of Ertugliflozin in rat plasma: Assessment of pharmacokinetic drug interaction potential of Ertugliflozin with Mefenamic acid and Ketoconazole”. Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences (2019): 1122-1123 (March), 49-57.
21. Wang W., et al. “Study on the interaction of Ertugliflozin with human serum albumin in vitro by multi-spectroscopic methods, molecular docking, and molecular dynamics simulation". Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy 219 (2019): 83-90.
22. Validation of Analytical Procedures: Text and Methodology, Proceedings of International Conference on Harmonization (ICH). Geneva, (2005).
23. International Conference on Harmonization (ICH) of Technical Requirements for the Registration of Pharmaceuticals for Human Use, Validation of Analytical Procedures, ICH-Q2A, Geneva (1995).

Citation

Citation: Arulselvan Murugesan and Annapurna Mukthinuthalapati Mathrusri. “Novel Simplified, New Analytical Method for Stress Degradation Study of Ertugliflozin an Oral Anti-diabetic Agent by RP-HPLC Method". Acta Scientific Pharmaceutical Sciences 5.12 (2020): 03-09.

Copyright

Copyright: © 2020 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.