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ISSN 2063-5346
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Optimization of gradient RP-HPLC method for simultaneous quantification of dapagliflozin and teneligliptin in bulk and tablet formulations and their validation

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Sandhya Pilli [a]*, Sri Nataraj Kalakonda[b], Vijayalakshmi Rajendran[
» doi: 10.48047/ecb/2023.12.10.837

Abstract

Background & Aim: The present RP-HPLC approach was created with the purpose of estimating Dapagliflozin and Teneligliptin in bulk and tablet formulations. It has been shown to be highly precise, straightforward, and stable. Materials & Methods: Eclipse XDB -C18, 150x4.6mm, 5micron column was pumped with a mobile phase of 0.025M potassium dihydrogen phosphate buffer (pH 2.50 adjusted by ortho-phosphoric acid) and acetonitrile in a gradient manner at a flow rate of 1.0 ml/min for chromatogram development. The optimal wavelength was 240 nm. The analysis was conducted at room temperature with a 20 μL injection volume. Results & Discussion: It was determined that the linearity ranges for Dapagliflozin and Teneligliptin are 2μg mL-1 to 12μg mL-1 and 4μg mL-1 to 24μg mL-1, respectively. Dapagliflozin and Teneligliptin had retention durations of 3.8 and 7.7 min, respectively. The percentage recovery of Commercial Formulation DPG and TNG was found to be 99% and 99.2% respectively. RSD value not more than 2.0% for both active ingredients indicate stability of the solutions. Conclusion: The above-mentioned method was found to be highly precise, accurate, robust and specific enough to quantify the selected drugs with good resolution and high sensitivity, and its application for routine quality analysis is supported by validated reports.

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