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Published on:November 2018
Indian Journal of Pharmaceutical Education and Research, 2018; 52(4s2):S277-S286
Research Article | doi:10.5530/ijper.52.4s.108

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

Authors and affiliation (s):

Swapna Goday1*, Abdul Rahaman Shaik1, Prameelarani Avula2

1Department of Pharmaceutical Analysis, Nirmala College of Pharmacy and Research Scholar JNTUK, Kakinada, Andhra Pradesh, INDIA.

2 Department of Pharmaceutics, University College of Pharmaceutical Sciences, Acharya Nagarjuna University Guntur, Andhra Pradesh, INDIA.


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.

Key words: Application to pk profile studies, Method development, Validation, Dapagliflozin, Saxagliptin, LC-ESI-MS/MS.



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