Analytical method development and validation for simultaneous estimation of sitagliptin and etruglifloxin in bulk and pharmaceutical dosage form by RP-HPLC

https://doi.org/10.54037/WJPS.2021.91210

Abstract

A simple, specific and accurate reverse phase high performance liquid chromatographic method was developed for the simultaneous determination Sitagliptin and Etruglifloxin in pharmaceutical dosage form. The column used was Discovery C₁₈(250mm x 4.6 mm, 5mm) in isocratic mode, with mobile phase containing phosphate buffer and acetonitrile (45:55 v/v). The buffer is prepared by adding accurately weighed 1.36gm of Potassium dihyrogen Ortho phosphate in a 1000ml of Volumetric flask add about 900ml of milli-Q water added and degas to sonicate and finally make up the volume with water then pH adjusted to 5.4 with dil. Orthophosphoric acid solution. The flow rate was 1.0ml/ min and effluents were monitored at 260 nm. The retention times of Sitagliptin and Etruglifloxin were found to be 2.381 min and 3.429 min, respectively. The linearity for Sitagliptin and Etruglifloxin were in the range of 25-150 µg/ml and 3.75-22.5 µg/ml respectively. The recoveries of Sitagliptin and Etruglifloxin were found to be 99.46 to 101.19% and 99.36 to 100.99%, respectively. The proposed method was validated and successfully applied to the estimation of Sitagliptin and Etruglifloxin in combined tablet dosage forms.