Develop a new, simple, fast, rapid, accurate, efficient and Reproducible RP-UPLC Method for the Simultaneous analysis of Metformin and Saxagliptin

A. Srikanth*, G. Srikanth¹, Shaik afroz begum², Machiraju Sai Kalyan³
*Associate Professor, Dept. of Pharmaceutical Analysis Vasavi institute of pharmaceutical sciences, Kadapa.
¹Assistant Professor, Dept. of Pharmaceutics, Vasavi institute of pharmaceutical sciences, Kadapa.
²Assistant Professor, Dept of Pharmaceutical Chemistry, Vasavi institute of pharmaceutical sciences, Kadapa.
³Student, Department of Pharmaceutical Analysis, Vasavi institute of pharmaceutical sciences, Kadapa.

Abstract
Introduction: Metformin decreases blood glucose levels by decreasing hepatic glucose production, decreasing intestinal absorption of glucose, and improving insulin sensitivity by increasing peripheral glucose uptake and utilization. These effects are mediated by the initial activation by metformin of AMP-activated protein kinase (AMPK), a liver enzyme that plays an important role in insulin signaling, Saxagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor antidiabetic for the treatment of type 2 diabetes. Aim and Objectives: The present work is aimed to develop a new, simple, fast, rapid, accurate, efficient and reproducible RP-UPLC method for the simultaneous analysis of Metformin and Saxagliptin. The developed method will be validated according to ICH guidelines. Methods: In our study we used chemicals were water, Methanol, Acetonitrile, Ortho phosphoric acid, KH₂PO_4, K₂HPO_4, 0. 22µ Nylon filter, 0.45µ filter paper, RCm XR, Metformin  and Saxagliptin. The Instruments UPLC-auto sampler–PDA detector, U.V double beam spectrometer, Digital weighing balance (sensitivity 5mg), pH meter, Sonicator were used. Results and Discussion: The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study of Metformin and Saxagliptin was found in concentration range of 50µg-250µg and 5µg-25µg and correlation coefficient (r²) was found to be 0.999 and 0.999, % recovery was found to be 99.56% and 99.48%, %RSD for repeatability was 0.8 and 0.3, % RSD for intermediate precision was 1.1 and 0.3 respectively. The precision study was precision, robustness and repeatabilty. LOD value was 2.17 and 0.0372 and LOQ value was6.60and 0.1125 respectively. Conclusion: The study suggested RP-UPLC method can be used for routine analysis of Metformin and Saxagliptinin API and Pharmaceutical dosage form.
Keywords: Metformin, Saxagliptin, RP-UPLC, ICH guidelines, LOD, LOQ, Pharmaceutical dosage form.