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Volume 20, Issue 9
  • ISSN: 1573-4129
  • E-ISSN: 1875-676X

Abstract

Background and Objectives

A combination of empagliflozin and linagliptin in a fixed dosage was employed for treating individuals with a diagnosis of type 2 diabetes mellitus. A rapid, accurate, and sensitive liquid chromatography-tandem mass spectrometry method was devised and validated for simultaneous measuring empagliflozin and linagliptin levels in human plasma. This method provides a good analytical tool for bioequivalence and pharmacokinetic studies.

Methods

The separation was conducted employing a C8 column using a mobile phase consisting of acetonitrile (ACN, 2.5mM) and ammonium chloride (55:45). Optimal detection of the analytes and their deuterated internal standards was accomplished through electrospray ionization in the positive mode.

Results

Validation of standard curve concentrations linearity was carried out within the ranges of 1.500 – 500.000 ng/mL for empagliflozin and 0.050 – 7.000 ng/mL for linagliptin. Both drugs showed intra-batch and inter-batch precision (CV%) of less than 3.7%. The stability of the drugs was confirmed under various storage conditions, proving suitability for routine laboratory analysis.

Conclusion

This validated method is appropriate for pharmacokinetic studies and large-scale analysis with high precision and accuracy.

© 2024 Bentham Science Publishers
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2024-12-04
2025-07-13

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A Bioanalytical Method Using High-performance Liquid Chromatography-mass Spectrometry for Determining Empagliflozin and Linagliptin in Human Plasma: Application in Bioequivalence Pharmacokinetic Study
Current Pharmaceutical Analysis 20, 978 (2024); https://doi.org/10.2174/0115734129338148241202074530
/content/journals/cpa/10.2174/0115734129338148241202074530
/content/journals/cpa/10.2174/0115734129338148241202074530
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  • Article Type:     Research Article
Keyword(s): bioequivalence; Empagliflozin; LC-MS/MS; linagliptin; pharmacokinetic; protein precipitation; validation

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