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Development and Validation of a LC-ESI-MS/MS Based Bioanalytical Method for Dapagliflozin and Saxagliptin in Human Plasma

1, 1, 2

  1. 1Department of Pharmaceutical Analysis, Nirmala College of Pharmacy and Research Scholar JNTUK, Kakinada, Andhra Pradesh.
  2. 2Department of Pharmaceutics, University College of Pharmaceutical Sciences, Acharya Nagarjuna University Guntur, Andhra Pradesh.

CORRESPONDENCE

Swapna Goday

Department of Pharmaceutical Analysis, Nirmala College of Pharmacy and Research Scholar JNTUK, Kakinada, Andhra Pradesh.

swapna.goday.gs@gmail.com

Received: 05-12-2017; Accepted: 17-05-2018.

Volume 52, Issue 4s2 (Supplement) · pp. s277-s286 · 2018 · DOI: 10.5530/ijper.52.4s.108

ABSTRACT

Objective: To develop a new, rapid and sensitive LC-ESI –MS/MS method for the simultaneous estimation of Dapagliflozin and saxagliptin in human K2EDTA plasma by Liquid –liquid Extraction method (LLE) using deutereated dapagliflozin (DGd2) and saxagliptin (SGd5).Method: Chromatographic separation was carried out on a reverse phase hypersil Gold C 18 (50mmx3.0mm, 5µm) column using mixture of 10 mM Ammonium acetate and methanol (20:80, v/v) at a flow rate of 0.5ml/min in isocratic mode. Quantification was achieved using an electro spray ion interface operating in positive mode, under multiple reaction monitoring (MRM) conditions.Results: The method showed excellent linearity over the concentration range of 50.00-10000.00 pg/mL for both the analytes. The intrabatch and inter batch precision (%CV) was ≤4.5% and Matrix effect (%CV) was1.27%, 1.20% for both the analytes.Conclusion: The simplicity of the method allows for application in laboratories, presents a valuable tool for bioavailability, bioequivalence, pharmacokinetic studies.

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    Goday, S., Shaik, A. R., & Avula, P. (2018). Development and Validation of a LC-ESI-MS/MS Based Bioanalytical Method for Dapagliflozin and Saxagliptin in Human Plasma. Indian Journal of Pharmaceutical Education and Research, 52(4s2), s277-s286. https://doi.org/10.5530/ijper.52.4s.108

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    © 2018 Author(s)

    This is an open access article distributed under the terms of the Creative Commons Attribution 4.0 License, which permits unrestricted use, distribution and reproduction in any medium, provided the original author and source are credited. CC BY 4.0