Volume : 13, Issue : 01, January – 2026
Title:
DEVELOPMENT AND VALIDATION OF A NEW ANALYTICAL RP-HPLC METHOD FOR THE SIMULTANEOUS DETERMINATION OF ANTI-DIABETIC AGENTS EMPAGLIFLOZIN AND LINAGLIPTIN IN BULK AND MARKETED FIXED-DOSE COMBINATION
Authors :
D. Swapna*, G. Maheshwari, K. Vanitha Prakash
Abstract :
Objective: To develop a simple, selective and rapid reverse phase high performance liquid chromatography (RP-HPLC) method and validate as per ICH guidelines for simultaneous determination of Empagliflozin and Linagliptin in a combined dosage form.
Methods: The chromatographic separation of the two anti-Diabetic drugs were achieved using Phenomenex Luna C18 (4.6mm×150mm, 5µm) Particle size, maintained at 38 °C throughout the analysis. The drugs were separated in isocratic elution mode with a mobile phase of Methanol: Tri Ethyl Amine Buffer (35:65% v/v) at a flow rate of 1.0 mL/min and a detection wavelength of 261 nm using a PDA detector.
Results: The linearity and range for Empagliflozin and Linagliptin were 60 to 140 mg/mL (R2> 0.9997) and 100 to 500 mg/mL (R2> 0.9997), respectively. Mean recoveries observed for Empagliflozin and Linagliptin were 100.36% and 100.15%, respectively. The precision of the method obtained was for Empagliflozin and for Linagliptin with a relative standard deviation less than 2%. The lower degree of % RSD that was obtained for intermediate precision has proved that the method is robust and rugged.
Conclusion: A simple and rapid RP-HPLC method was developed and validated for simultaneous determination of Empagliflozin and Linagliptin in a combined dosage form and hence, it can be used in the quality control analysis of an active pharmaceutical ingredient and pharmaceutical dosage form.
Key Words: Empagliflozin and Linagliptin, RP-HPLC, ICH Guidelines.
Cite This Article:
Please cite this article in press D. Swapna et al., Development And Validation Of A New Analytical Rp-Hplc Method For The Simultaneous Determination Of Anti-Diabetic Agents Empagliflozin And Linagliptin In Bulk And Marketed Fixed-Dose Combination, Indo Am. J. P. Sci, 2026; 13(01).
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