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

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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.