A New Stability Indicating Rp-Hplc Method For Simultaneous Estimation Of Sitagliptin And Ertugliflozin In Bulk And Tablet Dosage Form

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The present investigation was proposed to develop a simple, sensitive, rapid, accurate, precise stability-indicating RP-HPLC method for simultaneous estimation of sitagliptin and ertugliflozin. The chromatographic separation was performed on standard fortis C18 (4.6×100µm with 2.5µm particle size) at an ambient temperature. The samples were eluted using Methanol: Buffer solution (75:25v/v) as a mobile phase at a flow rate 0.8ml/minute. The common wavelength of absorption of Sitagliptin and Ertugliflozin was found to be 215.0nm. The chromatograms of the prepared standard stock solutions of Sitagliptin and Ertugliflozin were recorded under optimized chromatographic conditions.The retention time of STG and ERTU using optimum conditions was 3.02 and 6.58 minutes respectively. The present method was validated according to the ICH guidelines Q2 R1, and stability-indicating studies were carried out as per ICH guidelines Q1A R2. Intra-day and inter-day precision were found to be within acceptable limits. : The linearity was evaluated by determining six standard working solution drug, over range 66-396ug/ml and 10-60ug/ml and found to be linear with linear regression value 0.9996 and 0.9995 respectively. The LOD and LOQ were estimated 0.55μg/ml & 1.674μg/ml for Ertugliflozin and 2.80μg/ml and 8.485μg/ml for Sitagliptin. The limit of detection and quantitation limits performed based on the slope and standard deviation. To ascertain the accuracy of proposed method, recovery studies were carried out by standard addition method as per ICH guidelines and the mean percentage recovery of STG and ERTU was achieved between 99.97% and 100.86% respectively. Hence, the method was successfully implied for stability-indicating studies and for routine examination of sitagliptin and ertugliflozin in pharmaceutical formulation