Navyatha Gopu¹, Gunturu Jaya Syamala²*, Y Ankamma Chowdary³, Yelisetti Uma Mahesh⁴ and Pamarthi Amala Kumari⁵

¹Master of Pharmacy, Department of Pharmaceutical Quality Assurance, School of Pharmaceutical Sciences, Dr. RVR NRI Institute of Technology, Deemed to be University, Pothavarappadu (V), Agiripalli (M), Vijayawada Rural, Eluru District, Andhra Pradesh, India ²Assistant Professor, Department of Pharmaceutical Analysis, School of Pharmaceutical Sciences, Dr. RVR NRI Institute of Technology, Deemed to be University, Pothavarappadu (V), Agiripalli (M), Vijayawada Rural, Eluru District, Andhra Pradesh, India ³Dean, School of Pharmaceutical Sciences, Dr. RVR NRI Institute of Technology, Deemed to be University, Pothavarappadu (V), Agiripalli (M), Vijayawada Rural, Eluru District, Andhra Pradesh, India ⁴Associate Professor, Department of Biotechnology, School of Pharmaceutical Sciences, Dr. RVR NRI Institute of Technology, Deemed to be University, Pothavarappadu (V), Agiripalli (M), Vijayawada Rural, Eluru District, Andhra Pradesh, India ⁵Bachelor of Pharmacy, School of Pharmaceutical Sciences, Dr. RVR NRI Institute of Technology, Deemed to be University, Pothavarappadu (V), Agiripalli (M), Vijayawada Rural, Eluru District, Andhra Pradesh, India

*Corresponding Author: Gunturu Jaya Syamala, Assistant Professor, Department of Pharmaceutical Analysis, School of Pharmaceutical Sciences, Dr. RVR NRI Institute of Technology, Deemed to be University, Pothavarappadu (V), Agiripalli (M), Vijayawada Rural, Eluru District, Andhra Pradesh, India.

Received: September 08, 2026; Published: October 06, 2026

A simple, rapid, and economical reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the simultaneous estimation of Empagliflozin and Linagliptin in a combined pharmaceutical tablet formulation. Chromatographic separation was achieved on a C18 column (250 × 4.6 mm, 5 μm) using a mobile phase of phosphate buffer (pH 5.6) and acetonitrile in the ratio of 40:60 v/v, “dual-wavelength UV-Visible detector (Waters 2487)” — and drop “DUAL-WAVELENGTH UV DETECTOR (WATERS 2487)” throughout unless you actually used a DUAL-WAVELENGTH UV DETECTOR (WATERS 2487) module (e.g. Waters 2996), in which case correct the model number instead. Under these conditions, both drugs eluted within 6 minutes with sharp, symmetrical, and well-resolved peaks. The method was validated as per International Council for Harmonisation (ICH) Q2 (R2) guidelines for system suitability, specificity, linearity, precision, accuracy, robustness, limit of detection (LOD), and limit of quantification (LOQ). Linearity was established over 10 - 50 μg/mL for Empagliflozin and 20-100 μg/mL for Linagliptin, with correlation coefficients (r2) exceeding 0.999 for both analytes. Mean recoveries were 100.0% for Empagliflozin and 100.2% for Linagliptin, and the percentage relative standard deviation (%RSD) for repeatability and intermediate precision remained below 1% for both drugs, confirming excellent precision. The LOD and LOQ were 2.17 and 6.60 μg/mL for Empagliflozin, and 0.0372 and 0.1125 μg/mL for Linagliptin, respectively. Assay of a marketed fixed-dose tablet formulation gave recoveries of 100.6% and 99.4% for Empagliflozin and Linagliptin, respectively, confirming the accuracy of the method for finished dosage forms. The developed method is simple, sensitive, precise, accurate, and robust and is suitable for the routine quality control assay of Empagliflozin and Linagliptin in studied combined tablet formulation.

Keywords: Empagliflozin; Linagliptin; RP-HPLC; Method Validation; ICH Q2 (R2); Simultaneous Estimation

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Citation

Citation: Gunturu Jaya Syamala., et al. “RP-HPLC Method Development and Validation for the Simultaneous Estimation of Empagliflozin and Linagliptin in Pharmaceutical Formulation". Acta Scientific Medical Sciences 10.10 (2026): 91-99.

Copyright

Copyright: © 2026 Gunturu Jaya Syamala., 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.