Determination of Sitagliptin Levels in Rats Serum by HPLC and its Pharmacokinetic Investigation in Existence of Sucralose
It is an interest of the current work to develop a simple, valid and rapid chromatographic method for the quantification of sitagliptin in rats' serum. Accordingly, the pharmacokinetic parameters of sitagliptin was investigated for any possible interaction between sitagliptin and sucralose. The developed HPLC method was validated for sitagliptin determination in rat’s serum. Results indicated an accomplished overall intra-day precision and accuracy values of 0.139-4.028 (CV%) and 99.48-107.12% respectively. On the other hand, inter-day precision and accuracy results recorded values of 0.150-2.810 (CV%) and 99.90-116.00% respectively. Moreover, the coefficient of correlation was determined at a value of 0.99950 with reasonable sensitivity and selectivity. Effect of sucralose showed strong significant correlation on sitagliptin serum profile. The precise, accurate, linear, sensitive and selective HPLC method will be elaborated in the context of the current work with emphasis on sucralose negative effect on sitagliptin level in rat’s serum. Such finding is a guidance for physicians to reconsider the use of such sweeteners for diabetic patients
Dayyih WA., Tamimi L., Mallah E., Mansour K., Arafat T., Bustami M., 2015. Saxagliptin Levels and its Pharmacokinetic Application in Presence of Sucralose in Animals Serum by HPLC Method. Int. J. Parm. Pharmac. Sci. 7(9): 243-250.
Dayyih WA., Hamad M., Mallah E., Abu Dayyih A., Awad R., et al., 2018. METHOD Development and Validation of Vildagliptin and Metformin HCl in Pharmaceutical Dosage form by Reversed Phase-High Performance Liquid Chromatography (RP-HPLC), IJPSR. 9(7): 2965-2972.
Beconi MG., Reed JR., Teffera Y., Xia YQ., Kochansky CJ., et al., 2007. Disposition of the dipeptidyl peptidase 4 inhibitor STGPN in rats and dogs. Drug. Metabol. Dispos. 35(4): 525-532.
Dubal A., Khatwal R., Kosaraju J., Meda V., Samanta M., 2012. Bioanalytical method development and validation of STGPN phosphate by RP-HPLC and its application to pharmacokinetic study. Int. J. Parm. Pharmac. Sci. 4(2): 691-694.
El-Bagary RI., Elkady EF., Ayoub BM., 2011. Spectroflourometric and spectrophoto-metric methods for the determination of STGPN in binary mixture with metformin and ternary mixture with metformin and STGPN alkaline degradation product. Int. J. Biomed. Sci. 7(1): 62-69.
EMA. Guideline on Bioanalytical Method Validation. EMA, Committee for Medicinal Products for Human Use (CHMP), London, UK (2011).
Herma GA., Bergman A., Liu F., Stevens C., Wang AQ., et al., 2006. Pharmacokinetics and pharmacodynamic effects of the oral DPP-4 inhibitor STGPN in middle-aged obese subjects. J. Clinic. Pharmacol. 46(8): 876-886.
Khan AYP., Sabarwal NJA., Gupta A.K., 2011. Simultaneous Estimation of Metformin and Sitagliptin in tablet dosage form. Asian J Biochem pharmac Res.1(2): 352-358.
Matsubara T., Kim HK., Miyata M., Shimada M., Nagata K., Yamazoe Y., 2004. Isolation and characterization of a new major intestinal CYP3A form, CYP3A62, in the rat. J. Pharmacol. Exper. Therap. 309(3): 1282-1290.
Nikolaou P., Papoutsis I., Athanaselis S., Alevisopoulos G., Khraiwesh A., et al., 2011. Development and validation of a GC/MS method for the determination of tadalafil in whole blood. J. Pharmaceu. Biomed. Analy. 56(3): 577-581.
Nirogi R., Kandikere V., Mudigonda K., Komarneni P., Aleti R., 2008. Boggavarapu, R. Sensitive liquid chromatography tandem mass spectrometry method for the quantification of sitagliptin, a DPP-4 inhibitor, in human plasma using liquid–liquid extraction. Biomed. Chromatog. 22(2): 214–222.
Pathade A., 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. J. Pharmy. Rese. 4(3): 871-873.
Patil S., Ramesh B., Patil K., 2010. Dhokane, A. Development and Validation of RP-HPLC Method for the Estimation of STGPN Phosphate in Tablet Dosage Form. Asian. J. Rese. Chem. 3(3): 653-655.
Pulla RP., Sastry BS., Rajendra PY., Appala RN., 2011. Simultaneous Estimation of Metformin HCl and STGPN Phosphate in Tablet Dosage Forms by RP-HPLC. Res. J. Pharm. Techn. 4(4): 646-649.
Shyamala M., Mohideen S., Satyanarayana T., Narasimha R., Suresh K., Swetha K., 2011. Validated RP- HPLC for simultaneous estimation of Sitagliptin phosphate and Metformin in hydrochloride in tablet dosage form. Ame. J. Pharm.Tech. research. 1(2): 93-101.
Tamimi L., Abu Dayyih W., Qinna N., Mallah E., Arafat T., 2014. Pioglitazone HCl Levels and Its Pharmacokinetic Application in Presence of Sucralose in Animals Serum by HPLC Method. Pharmace. Analyt. Acta. 5: 318-325.
Vincent SH., Reed JR., Bergman AJ., Elmore CS., Shiyoa Xu EB., et al., 2007. Metabolism and excretion of the dipeptidyl peptidase 4 inhibitor [14C] STGPN in humans. Drug. Metabol. Dispos. 35(4): 533-538.
Zeng W., Xu Y., Constanzer M., Woolf EJ., 2010. Determination of Sitagliptin in human plasma using protein precipitation and tandem mass spectrometry. J. Chromatog. B. 878(21): 1817-1823.
Zeng W., Musson DG., Fisher AL., Chen L., Schwartz MS., et al., 2008. Determination of Sitagliptin in human urine and hemodialysate using turbulent flow online extraction and tandem mass spectrometry. J. Pharmaceu. Biomed. Analy. 46(3): 534-542.
- There are currently no refbacks.
Copyright (c) 2018 INDONESIAN JOURNAL OF PHARMACY
This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.
Indonesian J Pharm indexed by:View My Stats