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Assessment of Dapagliflozin by Using HPLC- Method Development, Validation and Stability Indicating Studies


Article Information

Title: Assessment of Dapagliflozin by Using HPLC- Method Development, Validation and Stability Indicating Studies

Authors: L. Siva Sanker Reddy, R. Nageswara Rao, K Raghavendra, Kumar Raja Jayavarapu, B. Indumathi, N. Madan Gopal, S. Muneer, B. Ushasree, L.A. Rama Prasad, Sampath Ayyappa G

Journal: Journal of Neonatal Surgery

HEC Recognition History
Category From To
Y 2023-07-01 2024-09-30
Y 2022-07-01 2023-06-30

Publisher: EL-MED-Pub Publishers

Country: Pakistan

Year: 2025

Volume: 14

Issue: 5S

Language: en

Keywords: ICH Guidelines

Categories

Abstract

This project's main objective is to develop and validate an RP-HPLC technique for dapagliflozin, an anti-diabetic medication that reversibly inhibits the human Sodium-Glucose Co-Transporter (SGLT2). The method should be easy to use, precise, and accurate. Methanol, ethanol, and isopropyl alcohol are among the organic solvents that dissolve it effectively. A p-value of 12.6 is provided. This experiment made use of the Column-C18 (5μm; 4.6×250mm). Acetonitrile and 1% IPA were combined in an 80:20 (v/v) ratio to create the selected mobile phase. 10 µg/ml was the injection volume, and 1.0 ml/min was the flow rate. A duration of retention of 2.9 minutes at 30°C was measured at 224 nm. With a r2 value of 0.9995, the range of linearity was found to be 5-100 µg/ml. A range of 98-102% was seen for the recovery. The respective limits of detection were 0.62 εg/ml and 0.2 εg/ml. The stress test results demonstrate that even in the presence of degradants, the method was still able to identify the medication.


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