IOSR Journal Of Pharmacy (e)-ISSN: 2250-3013, (p)-ISSN: 2319-4219 www.iosrphr.org Volume 5, Issue 8 (August 2015), PP. 34-40 34 Novel RP-HPLC Method for Simultanious Determination of Sitagliptin and Simvastation in Bulk and Tablet Dosage Form P. Ravisankar* 1 , SK. Hassain 1 , Shaik Mohammed Neeha 1 *1 Department of Pharmaceutical Analysis and Quality Assurance, Vignan Pharmacy College, Vadlamudi, Guntur - 522213, A.P., India. 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-C 18 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. Keywords: Sitagliptin and Simvastatin, RP-HPLC Method, Simultaneous estimation. I. INTRODUCTION The combination of SITA and SIMV is used together with a decorous diet and exercise to treat type 2 diabetes. It is also utilized together with a proper diet to treat high cholesterol and triglyceride (fats) levels in the blood. This medicine may help stop medical problems caused by clogged blood vessels such as heart attacks and strokes. SITA is a dipeptidyl peptidase - 4 inhibitor utilize to treat type 2 diabetes mellitus i.e., it helps to control blood sugar levels by increasing substances in the body that make the pancreas release more insulin. It also signals the liver to stop producing glucose when there is too much sugar in the blood and SIMV belongs to the group of medicines called statins and is used as HMG-CoA reductase inhibitor to lower the levels of LDL cholesterol. These two disorders commonly occur in patients at the same time, and have been typically treated with administration of these two drugs in separate tablets. The combination was approved in 2011 and is marketed as Juvisync by Merck. Currently, the combination tablet is approved in three doses: SITA/SIMV 100 mg/10 mg, 100 mg/20 mg, and 100 mg/40 mg. Literature survey revealed that there were few analytical methods have been reported for the simultaneous estimation of above said drugs individually, tertiary or in combination with some other drugs in biological samples as well as pharmaceutical dosage forms by UV- spectrophotometry [1-9] , HPLC [10-18] , HPTLC [19] , LC-MS/MS [20,21] ,Capilary zone electrophoresis [22] . All the above reported methods were based on the estimation of SITA/SIMV alone or in combination with other drugs. However most of the available methods have limitations such as long run time, poor resolution, uneconomical and low sensitivity. So based on the above mentioned reasons, indeed an attempt has been made to develop a simple, precise, accurate, reproducible and robust RP-HPLC method for the simultaneous determination of SITA and SIMV in pharmaceutical dosage form. The structural formulas of SITA and SIMV are shown in Fig. 1 and Fig. 2.