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September 10, 2025Journal of Neonatal SurgeryOpen Access

QbD-Driven Analytical Method Development and Validation for Linagliptin and Empagliflozin by RP-HPLC

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Analytical method demonstrates high precision and accuracy for linagliptin and empagliflozin, indicating robust quality control potential.

The developed method showcased outstanding linearity with correlation coefficients of 0.999 for both linagliptin and empagliflozin, ensuring reliability.
Validation included high accuracy with recovery rates between 98-102%, highlighting the method's effectiveness in pharmaceutical analysis.
A 2FI factorial design optimized method variables, significantly impacting retention time and chromatographic performance metrics.
Specificity was maintained with no interference detected, affirming its applicability for regular quality assessments in pharmaceuticals.

Kharwade et al. (2025) studied this question.

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Analytical method demonstrates high precision and accuracy for linagliptin and empagliflozin, indicating robust quality control potential.