A New RP-HPLC Method Development And Validation For The Simultaneous Estimation Of Remogliflozin Etabonate And Metformin In Pure Form And Marketed Dosage Form

Abstract

A new, precise, accurate, specific, rugged and sensitive, isocratic RP-HPLC stability indicating method has been developed and subsequently validated for the determination of Remogliflozin etabonate and Metformin in API and pharmaceutical dosage forms as per ICH guidelines. The separation achieved on a reversed phase Zorbax C18 (250 mm x 4.6 mm) 5µm Particle size Column as a stationary phase and  Mobile phase, Methanol: Phosphate Buffer pH-4.2 (80:20 v/v) and other conditions optimized were: flow rate (1.0 ml/minute), wavelength (250 nm), Run time was maintained at seven minutes. The retention time for remogliflozin etabonate and metformin was found to be 2.46 min and 4.32 min respectively. The stability of the drug was determined by studying the degradation of the drug under acidic, alkaline, peroxide, neutral, heat and UV conditions. The developed method was found to be linear in the range of 20-100µg/ml for of Remogliflozin etabonat and 40-120µg/ml for of Metformin with a correlation coefficient (r²) of 0.999. Recovery of Remogliflozin etabonate and Metformin was found to be in the range of 98-102% which confirms the accuracy of the method. The percentage purity of Remogliflozin etabonate and Metformin in pharmaceutical dosage form was found to be 99.87%. The limit of detection and the limit of quantification were found to be 0.75µg/ml and 3.30µg/ml respectively for of Remogliflozin etabonate and 1.56µg/ml and 6.28µg/ml respectively for Metformin. The sensitivity, accuracy, range, precision, robustness, ruggedness, stability, specificity, limit of detection, limit of quantification and system suitability parameters were validated for the developed method as per ICH Guidelines.