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

Research Article Volume 6 Issue 12

Development and Validation of a New Stability Indicating RP-UFLC Method for the Simultaneous Determination of Alogliptin and Metformin Tablets

Bandaru Sai Pavan Kumar and Mukthinuthalapati Mathrusri Annapurna*

Department of Pharmaceutical Analysis, Gandhi Institute of Technology and Management (Deemed to be University), GITAM School of Pharmacy, Visakhapatnam, Andhra Pradesh, India

*Corresponding Author: Mukthinuthalapati Mathrusri Annapurna, Department of Pharmaceutical Analysis, Gandhi Institute of Technology and Management (Deemed to be University), GITAM School of Pharmacy, Visakhapatnam, Andhra Pradesh, India.

Received: October 19, 2022; Published: November 30, 2022

Abstract

Alogliptin is a new hypoglycemic drug and Metformin is anti-diabetic drug. The combination of Alogliptin and Metformin is useful for the treatment of high blood sugar levels caused by type 2 diabetes. A new stability indicating RP-UFLC method has been developed for the simultaneous determination of Alogliptin and Metformin using mobile phase mixture consisting of tetra butyl ammonium hydrogen sulphate and methanol and validated. Shimadzu Model UFLC system with Agilent C18column and PDA detector with flow rate 0.6 mL/min with UV detection at 235 nm were the chromatographic conditions for the present study. Metforminshows linearity over the concentration range 0.05-100 mg/ml and the linear regression equation was found to bey = 10104x + 5157 (R² = 0.999) whereas Alogliptin shows linearity over the concentration range 0.1-25 mg/ml and the linear regression equation was found to be y = 75448x + 5118 (R² = 0.999). The LOQ and LOD of Metformin were found to be 0.0415 mg/ml and 0.01316 mg/ml respectively. The LOQ and LOD of Alogliptin were found to be 0.0961 mg/ml and 0.0309 mg/ml respectively. Stress degradation studies were performed and the method was validated as per ICH guidelines.

Keywords: Alogliptin; Metformin; RP-UFLC; Stability Indicating; Validation; ICH Guidelines

References

  1. Rena G., et al. “The mechanisms of action of Metformin”. Diabetologia9 (2017): 1577-1585.
  2. Radha A., et al. “Algliptin: A new addition to the class of DPP-4 inhibitors”. Diabetes, Metabolic Syndrome and Obesity 2 (2009): 117-126.
  3. Uche AN., et al. “Alogliptin: A new dipeptidyl peptidase-4 inhibitor for the management of type 2 diabetes mellitus”. American Journal of Health-System Pharmacy 71 (2014): 103-109.
  4. Ashutosh KS., et al. “New Validated Stability Indicating RP-HPLC Method for simultaneous estimation of Metformin and Alogliptin in human plasma”. Journal of Chromatography and Separation Techniques 6 (2015): 100293.
  5. Shereen M., et al. “Enhanced LC-MS/MS determination of Alogliptin and Metformin in plasma: Application to a pharmacokinetic study”. Microchemical Journal 130 (2017): 360-365.
  6. Sharma K and Parle A. “Development and validation of HPTLC method for simultaneous estimation of Metformin hydrochloride and Alogliptin benzoate in bulk drugs and combined dosage forms”. International Journal of Pharmaceutical Sciences Review and Research 11 (2015): 35-42.
  7. Runja C., et al. “Stability indicating RP-HPLC method for simultaneous estimation of Alogliptin benzoate and Metformin hydrochloride in tablet dosage form”. International Journal of Pharmacy and Pharmaceutical Sciences 1 (2016): 116-120.
  8. Praveen Kumar A., et al. “Analytical method development and validation of Alogliptin and Metformin hydrochloride tablet dosage form by RPHPLC method”. International Bulletin of Drug Research 5 (2013): 58-68.
  9. Indraja Nemallapudi. “Method development and validation of simultaneous estimation of Alogliptin and Metformin hydrochloride by RP-HPLC”. Asian Journal of Research in Chemistry and Pharmaceutical Sciences4 (2018): 206-214.
  10. Swathi Koduru., et al. “Method development for the simultaneous estimation of Metformin and Alogliptin by using RP-HPLC”. International Journal of Pharma Research and Health Sciences 3 (2015): 747-753.
  11. Magdy MA., et al. “Different chromatographic methods for determination of Alogliptin benzoate, Metformin hydrochloride, and Metformin impurity in bulk and pharmaceutical dosage form”. Journal of Separation Science4 (2021): 833-842.
  12. ICH Validation of analytical procedures: Text and methodology Q2 (R1) (2005).
  13. ICH Stability testing of new drug substances and products Q1A (R2) (2003).

Citation

Citation: Bandaru Sai Pavan Kumar and Mukthinuthalapati Mathrusri Annapurna. “Development and Validation of a New Stability Indicating RP-UFLC Method for the Simultaneous Determination of Alogliptin and Metformin Tablets". Acta Scientific Pharmaceutical Sciences 6.12 (2022): 68-76.

Copyright

Copyright: © 2022 Bandaru Sai Pavan Kumar and Mukthinuthalapati Mathrusri Annapurna. 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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