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

作者: Shruti Surendran , David Paul , Sunil Pokharkar , Abhijeet Deshpande , Sanjeev Giri

DOI: 10.1039/C8AY02087F

关键词:

摘要: Diabetes and its associated concerns constitute a major growing health issue in modern society. In the current work we report highly sensitive, selective specific LC-MS/MS method for estimation of novel anti-diabetic combination saxagliptin (SAX) dapagliflozin (DAP) rat plasma. An Agilent Eclipse Plus C18 column (150 mm × 4.6 mm, 3.6 μm) with gradient elution using 0.01% ammonia solution acetonitrile as mobile phase was used chromatographic separation. The ion transitions were quantified positive negative polarity switching approach. A solid extraction process sample preparation provided good linearity over range 0.2–80 ng mL−1 SAX 5–2000 DAP. validated according to US FDA bioanalytical guidelines successfully applied preclinical study simultaneous quantification DAP SD rats. developed analytical can also be utilized future clinical applications both drugs combined dosage form.

参考文章(18)
Iqra Hameed, Shariq R Masoodi, Shahnaz A Mir, Mudasar Nabi, Khalid Ghazanfar, Bashir A Ganai, Type 2 diabetes mellitus: From a metabolic disorder to an inflammatory condition World Journal of Diabetes. ,vol. 6, pp. 598- 612 ,(2015) , 10.4239/WJD.V6.I4.598
Jing-wen Gao, Yue-mei Yuan, Ya-song Lu, Mei-cun Yao, Development of a rapid UPLC‐MS/MS method for quantification of saxagliptin in rat plasma and application to pharmacokinetic study Biomedical Chromatography. ,vol. 26, pp. 1482- 1487 ,(2012) , 10.1002/BMC.2720
Sohita Dhillon, Saxagliptin: A Review in Type 2 Diabetes Drugs. ,vol. 75, pp. 1783- 1796 ,(2015) , 10.1007/S40265-015-0473-Z
Silvio E. Inzucchi, Richard M. Bergenstal, John B. Buse, Michaela Diamant, Ele Ferrannini, Michael Nauck, Anne L. Peters, Apostolos Tsapas, Richard Wender, David R. Matthews, Management of hyperglycaemia in type 2 diabetes, 2015: a patient-centred approach. Update to a Position Statement of the American Diabetes Association and the European Association for the Study of Diabetes Diabetologia. ,vol. 58, pp. 429- 442 ,(2015) , 10.1007/S00125-014-3460-0
Lily P.H. Yang, Saxagliptin Drugs. ,vol. 72, pp. 229- 248 ,(2012) , 10.2165/11208160-000000000-00000
Qin C. Ji, Xiaohui Xu, Eric Ma, Jane Liu, Shenita Basdeo, Guowen Liu, William Mylott, David W. Boulton, Jim X. Shen, Bruce Stouffer, Anne-Françoise Aubry, Mark E. Arnold, Selective reaction monitoring of negative electrospray ionization acetate adduct ions for the bioanalysis of dapagliflozin in clinical studies. Analytical Chemistry. ,vol. 87, pp. 3247- 3254 ,(2015) , 10.1021/AC5037523
D. S. H. Bell, Combine and conquer: advantages and disadvantages of fixed-dose combination therapy Diabetes, Obesity and Metabolism. ,vol. 15, pp. 291- 300 ,(2013) , 10.1111/DOM.12015