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September 28, 2025INDIAN DRUGS

Development and Validation of Rp-HPLC for Simultaneous Quantitation of Linagliptin, Dapagliflozin Propanediol Monohydrate and Metformin Hydrochloride: Greenness Evaluation by Agree and Gapi Tools

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Authors

SRSapna M. RathodSPSayema PothigaraNPNisarg C. Patel

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Overview

Method validation study demonstrates precise simultaneous RP-HPLC quantitation of linagliptin, dapagliflozin, and metformin, indicating its utility for eco-friendly pharmaceutical quality control.

Key Points

  • To develop and validate a precise, cost-effective, and environmentally sustainable RP-HPLC method for the simultaneous quantification of dapagliflozin, linagliptin, and metformin.
  • Chromatographic separation was achieved on an Agilent Eclipse XBD C18 column (5 µm, 150 × 4.5 mm) with an isocratic mobile phase of buffer (pH 3) and methanol (40:60 v/v) at 1.0 mL min⁻¹ and 215 nm detection.
  • Method greenness was quantitatively evaluated using the Analytical GREEnness (AGREE) metric and the Green Analytical Procedure Index (GAPI).
  • Linearity was confirmed across concentration ranges of 2.5–7.5 µg mL⁻¹ for dapagliflozin, 1.25–3.75 µg mL⁻¹ for linagliptin, and 125–375 µg mL⁻¹ for metformin.
  • Precision achieved percent relative standard deviation (% RSD) values under 2%, alongside acceptable recovery percentages meeting validation criteria.

Cite This Study

Rathod et al. (2025) studied this question.

synapsesocial.com/papers/6a75fae7f1e99ff85ab228e1https://doi.org/10.53879/id.62.09.15501
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  1. 1DEVELOPMENT, COMPUTATIONAL STUDIES AND VALIDATION OF SPECTROPHOTOMETRIC METHOD OF METFORMIN HYDROCHLORIDE IN PHARMACEUTICAL FORMULATIONS2020 · 26 citations
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