Development and Validation of RP-HPLC Method for Simultaneous Estimation of Sitagliptin and Simvastatin in Bulk and Tablet Dosage Form

Abstract

A simple reversed-phase high-performance liquid chromatographic (RP-HPLC) method has been developed and
validated for simultaneous determination of Sitagliptin and Simvastatin in bulk and tablet dosage form.
Chromatographic analysis was performed on a Nucleosil C18 (150X4.6 mm, 5µm) column ambient temperature
with a mixture of phosphate buffer and Acetonitrile in the ratio 30:70 (phosphate buffer preparation; 0.01 N
Potassium dihydrogen phosphate, pH 3.5 adjust with triethylamine) as mobile phase, at a flow rate of 1 mL
min-1
. UV detection was performed at 254 nm. The method was validated for accuracy, precision, specificity,
linearity and sensitivity. The retention times of Sitagliptin and Simvastatin were 3.242 min and 6.492 min,
respectively. Calibration plots were linear over the concentration ranges 25-150 μg mL-1
and 5-30 μg mL-1 for Sitagliptin and Simvastatin respectively. The Limit of detection was 1.305 µg mL-1 and 0.257 µg mL-1 and the quantification limit was 3.941µg mL-1 and 0.77µg mL-1 Sitagliptin and Simvastatin for respectively. The
accuracy of the proposed method was determined by recovery studies and found to be 99.20% to 100.94%.