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Concurrent Bio-Analysis and Validation of Empagliflozin, Dapagliflozin, Metformin and Linagliptin in Spiked Human Blood Plasma By RPLC-MS/MS
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| Author:
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TAMADRI DAS, NAGARAJAN JANAKI SANKARACHARI KRISHNAN, ANN RAICHEL JOHN
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| Abstract:
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A new simple, specific, and selective bioanalytical method was established for the concurrent quantification of Empagliflozin, Dapagliflozin, Metformin, and Linagliptin in spiked human blood plasma by RPLC-MS/MS and validated as per the USFDA guidelines. The enrichment of analytes from the plasma was accomplished by protein precipitation method by using Methyl alcohol. By adopting our method one can achieve the separation and estimation of Empagliflozin, Dapagliflozin, Metformin, and Linagliptin in combination forms, where one drug can act as an internal standard. The analytes were separated and analyzed by triple quadrupole mass spectrometer using photomultiplier tube as a detector, with the electron spray ionization technique of positive and negative mode on Zorbax SB octadecyl silica column (50mm x 3.6 mm i.d., 5µm) with a moving phase (10mMAmmonium Acetate Buffer (pH-5): Cyanomethane 20:80 v/v) at a 0.5 ml/min flow rate, with a run time of 5.0 min A Linear calibration plotted in the concentration range 7.5-150ng/ml ( Empagliflozin), 15.8-316ng/ml (Dapagliflozin), 6-120ng/ml( Metformin). LOD was found to be 2.450, 5.200, 1.95ng/ml, and LOQ were found to be 7.5, 1.50, 6.0 ng/ml for Empagliflozin, Dapagliflozin, and Metformin respectively. The Regression Coefficient was found to be 0.992, 0.996, and 0.995 for respective drugs. The established method was accurate and precise as per USFDA guidance for the industry, useful for Pharmacokinetic study and Bio-equivalence study.
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| Keyword:
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Bioanalysis, Empagliflozin, Dapagliflozin, Metformin, Linagliptin (IS), RPLC-MS/MS, USFDA Guidelines.
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2021.13.02.241
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| Download:
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