@article{Dhani_2021, title={Bioanalytical Method Development and Validation of Empagliflozin by LC–MS/MS Method and Quantitative Estimation of Drug Concentration in Human Plasma}, volume={15}, url={https://asiapharmaceutics.info/index.php/ajp/article/view/4103}, DOI={10.22377/ajp.v15i2.4103}, abstractNote={<p>Objective: The objective of this work is to develop rapid, selective, and sensitive liquid chromatography<br />tandem–mass spectrometry (LC–MS/MS) method for the quantitative estimation of empagliflozin. Sample<br />and standard solutions were prepared using methanol. Methodology: The chromatographic separation was<br />achieved with X Bridge C18 column (75 mm × 4.6 mm, 3.5 μ) using a mobile phase composition of acetonitrile<br />and 10 mM ammonium bicarbonate (70:30 V/V) at a flow rate of 0.8 mL/min with a run time of 2.40 min.<br />The method showed good linearity in the range of 2–1000 ng/mL with correlation coefficient (r) of >0.9998.<br />Results: The % CV of peak area ratio (analyte area/ISTD area) and % CV of retention times for analyte and<br />ISTD were within the acceptance criteria. There was no significant carry over observed during this experiment.<br />All the investigated human plasma lots were found to be free of significant interferences at the retention time<br />of drug and ISTD. The intra- and inter-day precision values for empagliflozin comply with the acceptance<br />criteria. The battery of stability studies, namely, bench-top, freeze-thaw, and long-term stability was performed.<br />All the stability studies showing the % C.V. of area responses for the replicate injections should be within<br />15%. Conclusion: The developed method was very simple, precise, reliable, sensitive, and robustness. The<br />retention time takes less time consumption and high sensitivity, the method applicable for routine analysis and<br />bioanalysis.</p>}, number={2}, journal={Asian Journal of Pharmaceutics (AJP)}, author={Dhani, Ramesh}, year={2021}, month={Aug.} }