ABSTRACT:
The Reverse Phase High performance liquid chromatography Method is one of the most sophisticated tool of the analysis. The RP-HPLC method was developed for the simultaneous estimation of metformin and empagliflozinin bulk and Pharmaceutical dosage form. The Potassium Dihydrogenphosphate buffer was pH 3.0 and the mobile phase was optimized with consists of Methanol: Potassium Dihydrogenphosphate buffer(PH3) mixed in the ratio of 60:30 % v/v. Cosmosil C18 Column (250mm x 4.6mm, Particle Size: 5micron) was used as stationary phase and retention time of Metformin HCL and Empagliflozin was found to be 5.2 min and 6.5 min respectively. The detection was carried out using UV-3000-M detector at 227nm. The solutions were chromatographed at a constant flow rate of 0.8 ml/min. the linearity range of metformin and empagliflozin were found to be from 40-200 µg/ml of metformin and 1-5µg/ml of empagliflozin. corelation coefficient value(R2)were found to be0.9991 and0.9988 for Metformin HCL and Empagliflozin . The % Recovery was found to be 100.04% and 100.06% for Metformin HCL and Empagliflozin respectively. The relative standard deviation for intra day and Intra day was found to be less than 2%. The rubustness was found to be satisfactory within the range . Limit of detection was found to be 0.247µg/ml for Metformin HCL and 0.051µg/ml for empagliflozin and Limit of quantitation was found to be 0.751µg/ml for Metformin HCL and 0.157µg/ml for empagliflozin. The degradation of drug was determined under acidic , alkaline, peroxide ,photolytic and thermal conditions .The results obtained on the validation parameters met ICH requirements .It inferred the method found to be simple, accurate, precise and linear hence it can be employed for routine laboratory analysis with high degree of accuracy and precision.
Cite this article:
Nachiket S. Dighe, Ganesh S. Shinde, Jyoti. J. Vikhe. Simultaneous Estimation, Validation and Force Degradation Study of Metformin Hydrochloride and Empagliflozin by RP-HPLC Method. Research J. Science and Tech. 2019; 11(2):135-147. doi: 10.5958/2349-2988.2019.00021.4