Development and Validation of RP-HPLC Method for the Estimation of Sitagliptin Phosphate in Tablet Dosage Form

Sai Lakshmi E, Sravya E, Sireesha D, Vasudha Bakshi

Abstract


A new simple, rapid, specific, accurate, precise and novel Reverse Phase High Performance Liquid Chromatography (RP-HPLC) method has been developed for the estimation of Sitagliptin Phosphate in the pharmaceutical dosage form. The chromatographic separation for Sitagliptin was achieved with mobile phase containing  methanol, Thermoscientific C18 column, (250x4.6 particle size of 5µ) at  room temperature  and UV detection at 248 nm. The compounds were eluted in the isocratic mode at a flow rate of 1ml/min. The retention time of Sitagliptin was 1.91min. The above method was validated in terms of linearity, accuracy, precision, LOD and LOQ  in accordance with ICH guidelines. 


Keywords


Sitagliptin; Method development; Validation; RP-HPLC;

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References


A.S.K.Sankar, Suraj Sythana (2013). Development and Validation for Simultaneous Estimation of Sitagliptin and Metformin in Pharmaceutical Dosage Form using RP-HPLC Method. International Journal of Pharma Tech Research. 5(4):1736-1744.

Baptist Gallwitz (2007). Review of sitagliptin phosphate: a novel treatment for type 2 diabetes. Vascular health and risk management. 3(2):203–210.

Daniel Ducker, Chris Easley and Peter Kirkpatrick (2007). Sitagliptin. Nat. Rev. Drug. Discov. 6:109-110. doi.org/10.1038/nrd2245

Geetha et al (2015). Analytical Method Development and Validation for Simultaneous Estimation of Metformine Hydrochloride and Pioglitazone by Using RP-HPLC. International Journal of Chemistry and Pharmaceutical Sciences. 3(11):2133-2141.

Guideline on Validation of Analytical Procedure-Methodology. International Conference on Harmonization, Geneva, Switzer- land, 1996.

Jain Pritam, Chaudhari Amar, Desai Bhargav, Patel Shani, et al (2011). Development and validation of first order derivative UV- Spectrophotometric method for determination of sitagliptin in bulk and in formulation. Int. J. Drug Dev & Res. 3(4):194-199.

K Ganesh et al (2016). Development and validation of UV spectrophotometric method for simultaneous estimation of metformin and Glipizide in tablet dosage form. Int. J. Appl. Pharm. Sci. Res.1(2):56-59. doi.org/10.21477/ijapsrv1i2.10176.

Nancy Veronica B et al (2014). Development and validation of a new simple RP-HPLC method for estimation of Metformin HCl and Sitagliptin phosphate simultaneously in bulk and dosage forms. Int J Adv Pharm Gen Res. 2(1):1-14.

Rakesh K. Patel, Vishal R. Patel, Madhavi G. Patel (2012). Development and validation of a RP-HPLC method for the simultaneous determination of embelin, rotterin and ellagic acid in vidangadi churna. Journal of Pharmaceutical Analysis. 2(5):366-371. .doi.org/10.1016/j.jpha.2012.03.001

T.Himabindu et al (2016). Development and validation of spectrophotometric method for the simultaneous estimation of metformin hydrochloride and sitagliptin phosphate in tablet dosage form . World Journal of Pharmaceutical Research. 5(7):1011-1018.




DOI: http://dx.doi.org/10.21477/ijapsr.v2i3.8099

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