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LC-MS/MS method for simultaneous estimation of novel anti-diabetic combination of Saxagliptin and Dapagliflozin using a polarity switch approach: application to in vivo rat pharmacokinetic study.

Abstract

Diabetes and its associated concerns constitute a major growing health issue in the modern society. In the current work we report a highly sensitive, selective and specific LC-MS/MS method for the estimation of novel anti-diabetic combination saxagliptin (SAX) and dapagliflozin (DAP) in rat plasma. Agilent Eclipse Plus C18 column (150 mm × 4.6 mm, 3.6 μm), with gradient elution using 0.01% ammonia solution and acetonitrile as mobile phase were used for the chromatographic separation. The ion transitions were quantified in positive and negative polarity using polarity switching approach. Solid phase extraction process was used as sample preparation approach. The method provided good linearity over the range of 0.2-80 ng/mL for SAX and 5-2000 ng/mL for DAP. The method was validated according to US FDA bioanalytical guidelines and successfully applied in preclinical study for simultaneous quantification of SAX and DAP in SD rats. The developed analytical method can also be utilized for the future clinical applications of both the drugs in combined dosage form.

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Publication details

The article was received on 24 Sep 2018, accepted on 11 Nov 2018 and first published on 16 Nov 2018


Article type: Paper
DOI: 10.1039/C8AY02087F
Citation: Anal. Methods, 2018, Accepted Manuscript
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    LC-MS/MS method for simultaneous estimation of novel anti-diabetic combination of Saxagliptin and Dapagliflozin using a polarity switch approach: application to in vivo rat pharmacokinetic study.

    S. Surendran, D. Paul, S. Pokharkar, A. Deshpande, S. Giri and N. SatheeshKumar, Anal. Methods, 2018, Accepted Manuscript , DOI: 10.1039/C8AY02087F

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