Method Development and Validation for the Simultaneous Estimation of Empagliflozin and Linagliptin in Bulk and Tablet Dosage Form by using HPLC

Authors: Gorantla Nagamallika, Vamshkrishna T, Ravindar Bairam, Manjunath SY, Nagi Reddy. N, Balakrishnaiah. P.

Country: India

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Abstract: It was discovered that empagliflozin and ligandipitin may be measured simultaneously using the RP-HPLC technique.The chromatographic separations were performed using a mobile phase consisting of 0.1% and an Agilent Eclipse column (4.6 x 150mm, 5m). A 280 nm PDA detector was used in conjunction with a waters HPLC auto sampler and a separation module 2695 HPLC system to detect TEA:Methanol (30:70) at a flow rate of 1 ml/min. The duration is ten minutes. Empagliflozin had a retention duration of 1.053 minutes and ligandiliptin 2.677 minutes. Empagliflozin had a linearity correlation coefficient value of 0.999 and a concentration range of 20-100 μg/ml, while Linagliptin had a value of 10-50 µg/ml. The overall recovery for Empagliflozin was determined to be 100% and for Linagliptin it was also determined to be 100%. empagliflozin limit of detection 3.07 and 10.09. Levels of detection for ligandipitin were 2.95 and 9.93, respectively. This study's findings suggest that the suggested RP-HPLC technique might be beneficial for routinely estimating Empagliflozin and Linagliptin in bulk and tablet dose forms, as it is simple, accurate, precise, rugged, robust, rapid, and repeatable.

Keywords: Empagliflozin, Linagliptin, RP‐HPLC, Simultaneous estimation.

Paper Id: 232831

Published On: 2025-11-25

Published In: Volume 13, Issue 6, November-December 2025

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