Abstract
A simple, sensitive and reproducible spectrophotometric method was developed for the determination of sitagliptin phosphate in bulk and in pharmaceutical formulations. The proposed method is based on condensation of the primary amino group of sitagliptin phosphate with acetyl acetone and formaldehyde producing a yellow colored product, which is measured spectrophotometrically at 430nm. The color was stable for about 1 hour. Beer’s law is obeyed over a concentration range of 5-25 μg/ml. The apparent molar absorptivity and Sandell sensitivity values are 1.067 x 104 Lmol-1cm-1 and 0.0471 μgcm-2 respectively. All the variables were studied to optimize the reaction conditions. No interference was observed in the presence of common pharmaceutical excipients. The validity of the method was tested by analyzing sitagliptin phosphate in its pharmaceutical preparations. Good recoveries were obtained. The developed method was successfully employed for the determination of sitagliptin phosphate in various pharmaceutical preparations.
Highlights
Sitagliptin phosphate(STP)(1-4) is 1,2,4-triazolo[4,3-a]pyrazine,7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl), phosphate, whose structure is given in the Fig. 1
A simple, sensitive and reproducible spectrophotometric method was developed for the determination of sitagliptin phosphate in bulk and in pharmaceutical formulations
The proposed method is based on condensation of the primary amino group of sitagliptin phosphate with acetyl acetone and formaldehyde producing a yellow colored product, which is measured spectrophotometrically at 430nm
Summary
Sitagliptin phosphate(STP)(1-4) is 1,2,4-triazolo[4,3-a]pyrazine,7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-, phosphate, whose structure is given in the Fig. 1. It is used in the treatment of diabetes. Literature survey reveals that only LC-MS [5,6,7,8] methods were reported for the determination of sitagliptin phosphate in plasma and urine of humans, rats and dogs. No assay procedure has been reported for the determination of this drug in its pharmaceutical formulations. This study presents new spectrophotometric method for the determination of sitagliptin phosphate in bulk and pharmaceutical formulations. The developed method is based on the reaction of sitagliptin phosphate with acetyl acetone and formaldehyde producing Hantzsch product
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