eng Oriental Scientific Publishing Company Biosciences Biotechnology Research Asia 0973-1245 2025-09-30 22 3 1136 1146 10.13005/bbra/3429 56091 article Kiran Prakash Surywanshi 1 Shivraj Popat Jadhav 1 Khemchand Rajendra Surana 2 Parag Ashok Pathade 3 Sunil Kashinath Mahajan 2 Department of Pharmaceutics, Divine College of Pharmacy, Satana, Nashik, Maharashtra, India Department of Pharmaceutical Chemistry, Divine College of Pharmacy, Satana, Nashik, Maharashtra, India Department of Pharmaceutical Chemistry, KBHSS Trust’s Institute of Pharmacy, Malegaon, Nashik Remogliflozin etabonate, a selective inhibitor of SGLT2, is prescribed for managing type 2 diabetes mellitus. To support quality control and routine testing, a dependable and efficient analytical technique is essential. The present study consists of a rapid, precise, and straightforward Reverse-Phase High-Performance Liquid Chromatography (RP-HPLC) method development for quantifying remogliflozin etabonate. An Inertsil ODS-3V column (150*4.6 mm, 5 µm) was used for separation. Optimization of the mobile phase was done from methanol: water (70:30, v/v) to acetonitrile: water (75:25, v/v), flow rate of 1.0 mL/min, and samples were analysed at 230 nm using a UV detector. ICH Q2(R1) was followed for validation of the method to assess various parameters like linearity, accuracy, precision, robustness, LOD, and LOQ. The assay demonstrated excellent linearity over 10–50 µg/mL (R² = 0.999), with a retention time of 2.55 min. Precision results showed %RSD values below 2%, while recovery studies confirmed accuracy within 98–102%. The calculated LOD and LOQ were 0.22 µg/mL and 0.68 µg/mL, respectively. The validated technique proved to be simple and robust, with adequate specificity, and can be effectively applied for routine analysis of remogliflozin etabonate in bulk as well as pharmaceuticals. https://www.biotech-asia.org/vol22no3/development-and-validation-of-a-robust-rp-hplc-method-for-the-estimation-of-remogliflozin-etabonate-in-bulk-and-tablet-dosage-forms/ Method development; Remogliflozin etabonate; RP-HPLC; SGLT2 inhibitor; Validation