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

  • Swapna Goday1Department of Pharmaceutical Analysis, Nirmala College of Pharmacy and Research Scholar JNTUK, Kakinada, Andhra Pradesh.
  • Abdul Rahaman Shaik
  • Prameelarani Avula2 Department of Pharmaceutics, University College of Pharmaceutical Sciences, Acharya Nagarjuna University Guntur, Andhra Pradesh, INDIA.

Volume 52 Issue 4s2 Pages s277-s286

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.

Keywords

  • Application to pk profile studies
  • Method development
  • Validation
  • Dapagliflozin
  • Saxagliptin
  • LC-ESI-MS/MS
IJOPP

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