Suba Geetha A*, Saravanan VS, Jambulingam M, Ravi Kumar R and Jayakarthi M

The Erode College of Pharmacy, Erode, Tamil Nadu, India

*Corresponding Author: Suba Geetha A, The Erode College of Pharmacy, Erode, Tamil Nadu, India.

Received: May 10, 2024; Published: July 03, 2024

Abstract

The simple, rapid, accurate, economic and a gradient RP-HPLC method showed excellent sensitivity, reproducibility, accuracy, and repeatability for the simultaneous estimation of Sitagliptin and Metformin in bulk and tablet formulation was developed and validated as per the ICH Guidelines and comparative studies were performed with different brands on same combination with same dose.

Method: It was performed by using C18250×4.6mm 5μ at low- pressure gradient method with the detection on UV at 261nm. The mobile phase comprises of mixture of buffer (pH 4) and acetonitrile at the ratio of 60:40 at the flow rate of 1 ml/min by keeping the column oven temperature up to 30°C throughout the analysis.

Result and Discussion: The retention time for Metformin was found to be 2.4 mins and for Sitagliptin 7.0 mins. This method shows good linearity on the concentration 1-5μg/ml for Metformin and 5-25μg/ml for Sitagliptin with the correlation coefficient (r2) of 1.0 and 0.996 for Metformin Sitagliptin respectively. The Limit of Detection and Limit of Quantification of Metformin was found to be 0.011 and 0.033 and for Sitagliptin 0.002 and 0.007 respectively.

Keywords: RP-HPLC; Diabetes Mellitus

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Citation

Citation: Suba Geetha A., et al. “Method Development and Validation of Simultaneous Estimation of Sitagliptin Phosphate and Metformin Hydrochloride by RP-HPLC Method – A Comparative Study".Acta Scientific Pharmaceutical Sciences 8.8 (2024): 02-08.

Copyright

Copyright: © 2024 Suba Geetha A., et al. 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.