Novel RP-HPLC Method for Simultanious Determination of Sitagliptin and Simvastation in Bulk and Tablet Dosage Form

Abstract

A simple, rapid, accurate, precise and novel high-performance liquid chromatographic method for simultaneous analysis of Sitagliptin (SITA) and Simvastation (SIMV) in pharmaceutical dosage form has been developed and validated. The chromatographic separation was accomplished on Welchrom RP-C18 Column (250 mm X 4.6 mm; 5μm), Shimadzu LC-20AT Prominence Liquid Chromatograph and with a mixture of 10 mM Phosphate buffer: acetonitrile and methanol in the range of (45:35:20 v/v/v). The flow rate was fixed at 1mL/minute and the analysis was performed using Shimadzu SPD-20A Prominence UV-detection was performed at 255 nm. The SITA and SIMV were separated within seven minutes. The retention time for SITA and SIMV was found to be 3.352 minutes and 5.402 minutes respectively. The calibration plots were linear over the concentration range of 10-50 μg/ml for SITA (r 2 = 0.9998) and 4-20 μg/ml for SIMV (r 2 = 0.9999). There was no interference due to commonly used excipients. The relative standard deviation for inter-day precision was lower than 2.0 % which obviously indicates that the present method was said to be highly precise. Regarding accuracy of the developed method the % RSD were also found less than 2 % which shows the method is completely accurate. The method was very sensitive with regard to LOD 0.681 μg/ml, 0.116 μg/ml and LOQ 2.250 μg/ml, 0.384 μg/ml respectively. The mean assay values for SITA and SIMV were determined in tablet dosage form were found to be within limits. The developed RP HPLC method was found to be simple, rapid, sensitive, highly precise and accurate highly suitable for routine analysis of drug samples containing SITA and SIMV.