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VOL. 11, ISSUE 3 (2026)
Bioanalytical method development and validation for simultaneous quantification of Empagliflozin and Linagliptin in human plasma by RP-HPLC
Authors
Dr. M Sreelakshmi, Kodamala Harsha Vardhan
Abstract
A simple, rapid and sensitive reversed-phase high-performance liquid
chromatographic (RP-HPLC) method was developed for simultaneous determination
of empagliflozin and linagliptin in human plasma using telmisartan as an
internal standard. Chromatographic separation was achieved on a Discovery C18
(250 × 4.6 mm, 5 µm) column using an isocratic mobile phase consisting of 0.1%
perchloric acid buffer (pH 4.5) and acetonitrile (68:32, v/v), at a flow rate
of 1.0 mL/min. Detection was performed at 218 nm with a 10 µL injection volume
and a total run time of 10 min. Plasma samples were processed by simple protein
precipitation with acetonitrile. The retention times of telmisartan,
empagliflozin and linagliptin were approximately 4.10, 4.76 and 6.46 min,
respectively. Both analytes showed linearity over 0.01-10 µg/mL, with reported
correlation coefficients of 0.999 for empagliflozin and 0.998 for linagliptin.
The method showed acceptable selectivity, system suitability, precision,
accuracy, ruggedness and stability under the conditions evaluated. Extraction
recovery was 55.16-66.12% for empagliflozin and 54.39-67.72% for linagliptin.
The method uses low plasma volume, a single-step extraction procedure and a
short isocratic run, making it potentially useful for routine bioanalytical
quantification and pharmacokinetic or bioequivalence studies.
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Pages:66-70
How to cite this article:
Dr. M Sreelakshmi, Kodamala Harsha Vardhan "Bioanalytical method development and validation for simultaneous quantification of Empagliflozin and Linagliptin in human plasma by RP-HPLC". International Journal of Research in Pharmacy and
Pharmaceutical Sciences, Vol 11, Issue 3, 2026, Pages 66-70
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