A novel RP-HPLC method for simultaneous determination of Ertugliflozin and Sitagliptin in bulk and tablet dosage form

Abstract

A simple, rapid, accurate, precise and novel Reverse-Phase High-Performance Liquid Chromatographic method for simultaneous analysis of Ertugliflozin and Sitagliptin in pharmaceutical dosage form has been developed and validated. The chromatographic separation was accomplished on Waters RP-C18 Column (250 mm X 4.6 mm; 5µm), Waters (Waters, Milford, MA, USA) Liquid Chromatograph and with a mixture of OPA (Ortho Phosphoric acid) 0.2%v/v: Acetonitrile (60:40 v/v). The flow rate was fixed at 1 mL/min and the analysis was performed using Waters, model 2998 UV-detection was performed at 250 nm. Ertugliflozin and Sitagliptin were separated within six minutes. The retention time for Ertugliflozin and Sitagliptin was found to be 2.375 minutes and 3.955 minutes respectively. The calibration plots were linear over the concentration range of 32.50 – 97.50 µg/ml for Ertugliflozin (r2 = 0.9992) and 216.50 – 649.50 µg/ml for Sitagliptin (r2 = 0.9992). There was no interference due to commonly used excipients. The relative standard deviation for inter-day precision was lower than 2.0% which indicates that the present method was said to be highly precise. Regarding the accuracy of the developed method the mean % recoveries were found to be 100.67 and 100.69 % for Ertugliflozin and Sitagliptin respectively, which shows the method is completely accurate. The LOD and LOQ for Ertugliflozin of the proposed method were found to be 0.0068µg/ml and 0.029 µg/ml for Sitagliptin 0.104 µg/ml and 0.347 µg/ml respectively. The mean assay values for Ertugliflozin and Sitagliptin 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 Ertugliflozin and Sitagliptin.