Development and Validation of a RP-HPLC Method for Simultaneous Determination of Remogliflozin Etabonate and Vildagliptin in Pure Form and Its Pharmaceutical Dosage Form
Keywords:Remogliflozin and Vildagliptin, RP-HPLC, Validation, Accuracy, Precision.
A simple, rapid, economical, precise and accurate RP-HPLC method for simultaneous estimation of Remogliflozin and Vildagliptinin API form and its Marketed Tablet Dosage Form has been developed and validated as per ICH Guidelines. The separation was achieved by Develosil (250mm x 4.6mm) 5µm Particle size Column and Methanol: Acetate Buffer pH-5.6 (35:65 v/v) used as mobile phase, at a flow rate of 1 ml/min. Detection was carried out at 262 nm. Retention time of Remogliflozin and Vildagliptin were found to be 2.345 min and 3.287 min, respectively. The developed method was validated in terms of system suitability, selectivity, linearity, precision, accuracy, limits of detection and quantification for the impurities following the ICH guidelines. Linearity observed for Remogliflozin (10-30μg/ml) and for Vildagliptin (30-70μg/ml). The percentage recoveries of Vildagliptin and Remogliflozin were 100.06% and 100.373% respectively. The developed method is fast, accurate, precise and sensitive hence it can be employed for routine quality control of tablets containing both drugs in quality control laboratories and pharmaceutical industries.