Abstract

Analytical Method Development and Validation of Dapagliflozin Enantiomer and Other Related Impurities in API Form with Cost Effective and Green Approach

Author(s): Bhagvan Kamaliya*, Shakil Sait, Adam Elias, Nilesh Dumbre, Santosh Takale, Mahendra Durgavale and Chetan Doshi

The principle of Green Analytical Chemistry (GAC) is increasingly being adopted to support efforts in controlling global environment pollution. In this context, a novel, efficient and reliable Reverse-Phase High-Performance Liquid Chromatography (RP-HPLC) method was developed and validated to quantify Dapagliflozin enantiomers along with associated impurities in its Active Pharmaceutical Ingredient (API) form, following International Council for Harmonization (ICH) guidelines. The chromatographic analysis employed a gradient elution system using mobile phase composed of acetonitrile and water in ratios of 95:5 v/v (Mobile phase A) and 5:95 v/v (Mobile phase B). Separation was performed on a Chiralcel OJ-3R column with the flow rate of 1.0 ml/min and detection was carried out at 227 nm using a UV detector. The Dapagliflozin enantiomer was eluted at approximately 14.9 minutes. The method demonstrated excellent linearity within the concentration range of 0.45 to 1.2 µg/ml, achieving a correlation coefficient (r²) of 1.000. Key validation parameters-including specificity, accuracy, precision, detection and quantification limits (LOD and LOQ), linearity, robustness and solution stability were evaluated and found to meet acceptable standards. Overall, this work introduces a validated, eco-friendly RP-HPLC method suitable for the accurate analysis of Dapagliflozin enantiomers and related impurities in pharmaceutical raw materials.

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