Development and Validation of RP-HPLC Method for Simultaneous Estimation of Acarbose and Dapagliflozin in Combined Mixture

Author Name : Krimisha Makwana, Dr. Sibaji Sarkar, Mr. Dhirendra Kumar Tarai

ABSTRACT

Dapagliflozin and Acarbose was found to degrade significantly in acidic and alkaline conditions as well as in photolytic degradation and under oxidative condition. Resolution of drug and the degradation products formed under different stress studies were successfully achieved on a Phenomenex C18 column (150×4.6mm dimensions and 5 µm particle size , 15mM Ammonium acetate : acetonitrile (60:40) Flow rate was 1ml/min and at the detection wavelength of 249 nm. The method was validated with respect to linearity, precision, accuracy, selectivity. Linearity range of 30-70 µg/ml 3-7 µg/ml and Co-relation coefficient of 0.9999 and 0.9992. the assay recovery of 100.413± 0.142 to 99.78± 0.891% Dapagliflozin and 99.925 ± 0.221to 100.116 ± 0.120%. of Acarbose A simple, accurate and precise RP - HPLC method has been developed and validated as per ICH guideline for Simultaneous Estimation of Dapagliflozin and Acarbose In Synthetic mixture.