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. 2011 Mar;7(1):55-61.

Spectrophotometric methods for the determination of sitagliptin and vildagliptin in bulk and dosage forms

Ramzia I El-Bagary  1 , Ehab F Elkady, Bassam M Ayoub
Affiliations

Spectrophotometric methods for the determination of sitagliptin and vildagliptin in bulk and dosage forms

Ramzia I El-Bagary et al. Int J Biomed Sci. 2011 Mar.

Abstract

Simple, accurate and precise spectrophotometric methods have been developed for the determination of sitagliptin and vildagliptin in bulk and dosage forms. The proposed methods are based on the charge transfer complexes of sitagliptin phosphate and vildagliptin with 2,3-dichloro-5,6-dicyano-1,4-benzoquinone (DDQ), 7,7,8,8-tetracyanoquinodimethane (TCNQ) and tetrachloro-1,4-benzoquinone (p-chloranil). All the variables were studied to optimize the reactions conditions. For sitagliptin, Beer's law was obeyed in the concentration ranges of 50-300 μg/ml, 20-120 μg/ml and 100-900 μg/ml with DDQ, TCNQ and p-chloranil, respectively. For vildagliptin, Beer's law was obeyed in the concentration ranges of 50-300 μg/ml, 10-85 μg/ml and 50-350 μg/ml with DDQ, TCNQ and p-chloranil, respectively. The developed methods were validated and proved to be specific and accurate for the quality control of the cited drugs in pharmaceutical dosage forms.

Keywords: charge transfer reaction; pharmaceutical preparation; sitagliptin phosphate; spectrophotometry; vildagliptin.

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Figures

Figure 1
Figure 1
a, sitagliptin; b, vildagliptin.
Figure 2
Figure 2
Absorption spectra for the reaction products of 300 μg/ml of sitagliptin with DDQ solution a (A) and with p-chloranil solution a (B) and for the reaction product of 100 μg/ml of sitagliptin with TCNQ solution a (C).
Figure 3
Figure 3
Absorption spectra for the reaction products of 150 μg/ml of vildagliptin with DDQ solution b (A), 350 μg/ml of vildagliptin with p-chloranil solution b (B) and for the reaction product of 50 μg/ml of vildagliptin with TCNQ solution b (C).
Figure 4
Figure 4
Continuous variation plot of the reaction products of sitagliptin with DDQ (series 1), TCNQ (series 2) and P-chloranil (series 3).
Figure 5
Figure 5
Continuous variation plot of the reaction products of vildagliptin with DDQ (series 1), TCNQ (series 2) and P-chloranil (series 3).
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