Development of HPLC Method for Determination of Sitagliptin in Human Plasma using Fluorescence Detector by Experimental Design Approach

References

• Sweetman, S.C. (2007). Martindale: The Complete Drug Reference, 35th edition, Pharmaceutical Press, London.
   Google Scholar
• Tripathi, K.D. (2004). Essential of Medical Pharmacology. 5th Ed. Jaypee Brothers Medical publisher, New Delhi, P. 248–249.
   Google Scholar
• Sekaran, C.B., Rani, A.P. (2010). Development and validation of spectrophotometric method for the determination of DPP-4 inhibitor, Sitagliptin in its pharmaceutical preparations; International Journal of Pharmacy and Pharmaceutical Science. 2(4): 138–142.
   Google Scholar
• Pathade, P., Imran, M., Bairagi, V., Ahire, Y. (2011). Development and validation of stability indicating UV spectrophotometric method for the estimation of Sitagliptin phosphate in bulk and tablet dosage form; Journal of Pharmacy Research. 4(3): 871–873.
   Google Scholar
• Kupkar, S., Jadhav, S., Kunjir, V., Chaudhari, P. (2012). Simultaneous estimation of Sitagliptin and Metformin hydrochloride in bulk and dosage form by UV spectrophotometry. Journal of Pharmacy Research, 5(1): 580–582.
   Google Scholar
• Loni, A.B., Ghante, M.R., Sawant, S.B. (2012). Simultaneous UV spectrophotometric method for estimation of Sitagliptin phosphate and Metformin hydrochloride in bulk and tablet dosage form; Der Pharma Chemica. 4(3): 854–859.
   Google Scholar
• El-Bagary, R.I., Elkady, E.F., Ayoub, B.M. (2011). Spectroflourimetric and spectrophotometric methods for the determination of Sitagliptin in binary mixture with metformin and ternary mixture with Metformin and Sitagliptin alkaline degradation product; International Journal of Biomedical Science. 7(1): 62–69.
   PubMedGoogle Scholar
• Caglar, S., Önal, A., Toker, S. (2012). Determination of Sitagliptin with fluorescamine in tablets and spiked serum Samples by spectrofluorimetry and a degradation study; Journal of Current Pharmaceutical Analysis. 8: 278–285 doi: 10.2174/157341212801619270
   Web of Science ®Google Scholar
• Mancilha, T.P., Paula, C.E.R., Cassella, R.J., Pacheco, W.F. (2013). Direct determination of Sitagliptin in pharmaceutical formulations and its determination in urine after solid-phase extraction by spectrofluorimetry; the Journal of Biological and Chemical Luminescence. 28: 873–878. doi: 10.1002/bio.2449
   PubMed Web of Science ®Google Scholar
• Sankar, A.S.K., Sythana, S., Jhansi, A., Shanmugasundharam, P., Sumithra M. (2013). Development and Validation for Simultaneous Estimation of Sitagliptin and Metformin in Pharmaceutical Dosage Form using RP-HPLC Method; International Journal of PharmTech Research. 5(4): 1736–1744.
   Google Scholar
• Shyamala, M., Mohideen, S., Satyanarayana, T., Ch. Narasimha Raju, Suresh Kumar, P., Swetha, K. (2011). Validated RP-HPLC for simultaneous estimation of Sitagliptin phosphate and Metformin hydrochloride in tablet dosage form; American J. Pharm Tech. Res. 1(2): 93–101.
   Google Scholar
• Lavanya, R., Yunoos, M. (2013). Development and Validation of RP-HPLC method for the estimation of Sitagliptin Phosphate in Bulk and its Tablet Dosage Form; Journal of Advanced Pharmacy Education & Research. 3(4): 475–479.
   Google Scholar
• Dubala1, A., Khatwal, R., Kosaraju, J., Meda, V., Samanta, M.K. (2012). Bioanalytical method development and validation of Sitagliptin phosphate by RP-HPLC and its application to pharmacokinetic study; International Journal of Pharmacy and Pharmaceutical Science. 4(2): 691–694.
   Google Scholar
• Jiu, X.F., Shang, W., Chen, Y., Li, X. G., Wan, X. M., Zhou, T.Y., LUW. (2011). A high performance liquid chromatography method for the quantitative determination assay of Sitagliptin in rat plasma and its application in pharmacokinetics study; Journal of Chinese Pharmaceutical Science. 20: 63–69. doi: 10.5246/jcps.2011.01.009
   Google Scholar
• El-Bagary, R.I., Elkady, E.F., Ayoub, B.M. (2011). Liquid chromatographic determination of sitagliptin either alone or in ternary mixture with Metformin and sitagliptin degradation product. Journal of Talanta. 85: 673–680. doi: 10.1016/j.talanta.2011.04.051
   PubMed Web of Science ®Google Scholar
• Modi, D.K., Parejiya, P.B., Patel, B.H. (2013). A simple and sensitive HPTLC method for simultaneous determination of Metformin hydrochloride and Sitagliptin phosphate in tablet dosage form; Journal of Chemistry. 1–4.
   Google Scholar
• Patel, C.B., Motisariya, M.H., Shah, P.A., Patel, K.G., Gandhi, T.R. (2013). Validated HPTLC method for the simultaneous determination of Metformin hydrochloride and Sitagliptin phosphate in marketed formulation; International Journal of Analytical and Bioanalytical Chemistry. 3(1): 47–51.
   Google Scholar
• Nirogi, R., Kandikere, V., Mudigonda, K., Komarneni, P., Aleti, R., Boggavarapu, R. (2008). Sensitive liquid chromatography tandem mass spectrometry method for the quantification of sitagliptin, a DPP-4 inhibitor, in human plasma using liquid-liquid extraction; Biomedical Chromatography. 22(2): 214–222. doi: 10.1002/bmc.926
   PubMed Web of Science ®Google Scholar
• Bonde, S.L., Bhadane, R.P., Gaikwad, A., Katale, D., Gavali, S., Narendran, A.S. (2013). A simple and sensitive method for determination of Metformin and Sitagliptin in human plasma using liquid chromatography and tandem mass spectrometry; International Journal of Pharmacy and Pharmaceutical Sciences. 5(Suppl 3): 463–470.
   Google Scholar
• Zeng, W., Xu, Y., Constanzer, M., Woolf, E.J. (2010). Determination of Sitagliptin in human plasma using protein precipitation and tandem mass spectrometry. Journal of Chromatography B. 878(21): 1817–1823. doi: 10.1016/j.jchromb.2010.05.013
   PubMed Web of Science ®Google Scholar
• Zeng, W., Musson, D.G., Fisher, A. L., Chen, L., Schwartz, M. S., Woolf, E. J., Wang, A. Q. (2008). Determination of Sitagliptin in human urine and hemodialysate using turbulent flow online extraction and tandem mass spectrometry. J. Pharm. Biomed. Anal. 46(3): 534–542. doi: 10.1016/j.jpba.2007.11.003
   PubMed Web of Science ®Google Scholar
• Gananadhamu, S., Laxmikanth, V., Shantikumar, S., Sridhar, V., Geetha, C., Sandhya, C. (2012). Rapid LC-ESI-MS-MS Method for the Simultaneous Determination of Sitagliptin and Pioglitazone in Rat Plasma and Its Application to Pharmacokinetic Study; American Journal of Analytical Chemistry. 3: 849–858 doi: 10.4236/ajac.2012.312112
   Google Scholar
• Reddy, S., Ahmed, I., Ahmad, I., Mukhopadhyay, A., Thangam, S. (2015). Development and validation of a method for simultaneous estimation of Metformin and Sitagliptin in human plasma by LC-MS-MS and its Application in a bioequivalence study; Journal of Chromatographic schience. 53: 1549–1556 doi: 10.1093/chromsci/bmv055
   PubMed Web of Science ®Google Scholar
• Salim, M., El-Enany, N., Belal, F., Walash, M., Patonay, G. (2012). Simultaneous determination of sitagliptin and metformin in pharmaceutical preparations by capillary zone electrophoresis and its application to human plasma analysis; Analytical Chemistry Insights. 7: 31–46. doi: 10.4137/ACI.S9940
   PubMedGoogle Scholar
• Bezerra, M.A., Santelli, R.E., Oliveira, E.P., Villar, L.S., Escaleira, L.A., (2008). Response surface methodology (RSM) as a tool for optimization in analytical chemistry; Talanta. 76: 965–977. doi: 10.1016/j.talanta.2008.05.019
   PubMed Web of Science ®Google Scholar
• Caldas, L.F.S., Francisco, B.B.A., Netto, A.D.P., Cassella, R.J. (2011). Multivariate optimization of a spectrophotometric method for copper determination in Brazilian sugar cane spirits using Doehlert design; Michrochemical Journal. 99: 118–124 doi: 10.1016/j.microc.2011.04.008
   Web of Science ®Google Scholar
• US Food and Drug Administration, (2013). FDA Guidance for Industry: Bioanalytical Method Validation, Center for Drug Evaluation and Research (CDER), Rockville. MD.
   Google Scholar