*Corresponding Author: sdmankar655@gmail.com ; priyankasagar3322@gmail.com 288 DOI: https://doi.org/10.52756/ijerr.2023.v32.025 Int. J. Exp. Res. Rev., Vol. 32: 288-296 (2023) Development and validation of RP-HPLC method for simultaneous estimation of Ertugliflozin and Sitagliptin in bulk drug and tablet dosage form S. D. Mankar 1* , Priyanka Sagar 1* , Sanjay Bhawar, Suhas Siddheshwar and Santosh Dighe Department of Quality Assurance Technique, Pravara Rural College of Pharmacy, Pravaranagar, Rahta, Ahmednagar- 413737, India E-mail/Orcid Id: SM, sdmankar655@gmail.com, https://orcid.org/0000-0003-3991-9412; PS, priyankasagar3322@gmail.com, https://orcid.org/0009-0000-5224- 5921; SB, sanjay.bhawar@pravara.in, https://orcid.org/0000-0002-5345-0799; SS, ssiddheshwar@gmail.com, https://orcid.org/0000-0002-7944-9470; SD, santosh.dighe@pravara.in, https://orcid.org/0000-0003-3260-2981 Introduction Ertugliflozin, chemically known as (1S,2S,3S,4R,5S)- 5-[4-chloro-3-[(4-ethoxyphenyl) methyl] phenyl]-1- (hydroxymethyl)-6, 8-dioxabicyclo (3,2,1) octane-2,3,4- triol; (2S)-5-oxopyrrolidine-2-carboxylic acid, is a selective inhibitor of sodium-dependent glucose cotransporters (SGLT), more specifically type 2 diabetes (Fediuk et al., 2020). A new dipeptidyl peptidase-4 (DPP- 4) inhibitor drug with the chemical name (R)-3-Amino-1- (3-(Trifluoromethyl)-5,6-Dihydro- (1,2,4) Triazolo (4,3- A) Pyrazin-7(8h)-yl)-4-(2,4,5-Trifluorophenyl) Butan-1- One is sitagliptin. Sitagliptin is an inhibitor of the protease dipeptidyl peptidase-4 (DPP-4), which breaks down the incretin GLP-1. GLP-1 levels that are elevated or sustained can enhance the pancreas's ability to secrete insulin by blocking DPP-4. Sitagliptin reduces hepatic glucose overproduction while increasing insulin production. In order to address decreased insulin levels brought on by beta-cell malfunction and the liver's unchecked synthesis of glucose, sitagliptin only functions when blood sugar levels are raised (Davis et al., 2010). To treat type 2 diabetes, ertugliflozin and sitagliptin were administered in a combined dosage form. There have been a few reported validated analytical techniques for estimating ertugliflozin and sitagliptin by RP-HPLC method (China et al., 2019; Rajeswari et al., 2022; Venkateswara et al., 2018; Raju et al., 2021; Vilas et al., 2022). It was found that no economically validated method was available from the literature for simultaneous estimation of Ertugliflozin and sitagliptin in bulk and tablet dosage form. The goal of the present research is to develop and validate the economical RP-HPLC method for simultaneous estimation of ertugliflozin and sitagliptin in bulk drugs and tablet dosage forms. Article History: Received: 16 th Jun., 2023 Accepted: 21 st Aug., 2023 Published: 30 th Aug., 2023 Abstract: To treat type 2 diabetes, in a combined tablet dosage form the ertugliflozin and sitagliptin were administered. Considering the less complication and readily availability of HPLC, the main objective of present study was to develop a new, precise, accurate, linear, robust, and economical RP-HPLC method for the simultaneous estimation of ertugliflozin and sitagliptin in tablet dosage form. Effective chromatographic separation of Ertugliflozin and Sitagliptin was achieved on Kromasil C18 (5 μm 250 mm X 4.6 mm) and the mobile phase containing Methanol and 0.1% OPA in water isocratic elution mode at a flow rate of 1.0mL/min. with column temperature at 30 °C and the injection volume was 20 μL at column temperature at 30°C. At an isosbestic wavelength of 212 nm, ertugliflozin and sitagliptin were found to have retention times of 5.30 min. and 2.05 min., respectively. The method was proven to be precise (%RSD 2%), accurate (>90%), and specific for the simultaneous measurement of both drugs in tablets. As a result, the suggested method with excellent specificity, accuracy, precision, linearity and robustness as well as economical was useful for the regular quality control analysis of ertugliflozin and sitagliptin tablets. Keywords: Ertugliflozin, RP-HPLC, Sitagliptin, Tablet