Author(s): Deepthi R, Gowri Sankar D

Email(s): deepthi.pharma7@gmail.com

DOI: 10.52711/0974-360X.2021.00844   

Address: Deepthi R1*, Gowri Sankar D2
1Research Scholar, Department of Pharmaceutical Analysis and QA, Andhra University, Visakhapatnam - 530003, Andhra Pradesh, India.
2Professor, Department of Pharmaceutical Analysis and QA, Andhra University, Visakhapatnam - 530003, Andhra Pradesh, India.
*Corresponding Author

Published In:   Volume - 14,      Issue - 9,     Year - 2021


ABSTRACT:
Aim: The proposed study aimed to develop a novel ultra-performance liquid chromatography (UPLC) method for the estimation of Ertugliflozin and Sitagliptin in Bulk and Tablet dosage form and validate the method in accordance with the International Conference on Harmonization guidelines. Methods: The optimized conditions for the developed UPLC method are Acquity UPLC HIBRA C18 (100mm × 2.1mm, 1.8µ) column maintained at 30°C with a mobile phase consisting of Buffer (0.01N sodium hydrogen phosphate) pH adjusted to 4.0 with dil. orthophosphoric acid: Acetonitrile in the ratio of 60:40%v/v on isocratic mode at a flow rate of 0.3mL/min. Results and conclusion: The sample was detected at 220nm. The retention time for Ertugliflozin and Sitagliptin was deemed at 1.873min and 1.260min. The developed method was validated for accuracy, precision, specificity, ruggedness, robustness, and solution stability. The method obeyed Beer’s law in the concentration range of 3.75µg/mL to 22.5µg/mL for Ertugliflozin and 25µg/mL to 150µg/mL for Sitagliptin with a correlation coefficient of 0.999 for Ertugliflozin and Sitagliptin respectively. Forced degradation studies were conducted by exposing the drug solution to numerous stress conditions such as acidic, basic, peroxide, neutral, photolytic, and thermal conditions. The net degradation was considered within the limits, indicating that the drug is stable in stressed conditions. The developed method for the estimation of Ertugliflozin and Sitagliptin can be utilized for the routine analysis of Pharmaceutical dosage form.


Cite this article:
Deepthi R, Gowri Sankar D. A Novel UPLC Method for Simultaneous Estimation of Ertugliflozin and Sitagliptin in Bulk and Tablet Dosage Form. Research Journal of Pharmacy and Technology. 2021; 14(9):4859-2. doi: 10.52711/0974-360X.2021.00844

Cite(Electronic):
Deepthi R, Gowri Sankar D. A Novel UPLC Method for Simultaneous Estimation of Ertugliflozin and Sitagliptin in Bulk and Tablet Dosage Form. Research Journal of Pharmacy and Technology. 2021; 14(9):4859-2. doi: 10.52711/0974-360X.2021.00844   Available on: https://rjptonline.org/AbstractView.aspx?PID=2021-14-9-58


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