Doe Approach: A Validated Rp -Hplc Method For The Determination Of Dapagliflozin

Abstract

Background: Dapagliflozin is a competitive inhibitor of sodium / glucose co transporter 2 (SGLT2). It will Inhibiting the reabsorption of filtered glucose in the kidney leads to elevated urinary glucose excretion, thereby lowering blood Method: A new, simple, accurate, rapid, precise, reproducible and cost-effective RP-HPLC method for the quantitative estimation of Dapagliflozin in bulk and pharmaceutical dosage form. The developed RP-HPLC method for the quantitative estimation of Dapagliflozin is based on measurement of absorption at maximum wavelength 254 nm using 0.1% urea: methanol (35:65% v/v) as a solvent. The stock solution for Dapagliflozin was prepared, and subsequent suitable dilution was prepared in mobile phase to obtained standard curve. The standard solution of Dapagliflozin shows absorption maxima at 254 nm. Results: Dapagliflozin will obeys Beers -Lamberts law in the concentration range of 20 - 100μg/ml with regression 0.999 at 254nm.The overall % recovery was found to be 101.59% for Dapagliflozin which reflects that the method was free from the interference of impurities and other impurities, used in bulk and marketed dosage forms. The low value of % RSD was indicative of accuracy and reproducibility of the method. The % RSD for inter-day and intra-day precision was found to be 0.1 for Dapagliflozin respectively which is & it <2% hence proved that method is precise. Conclusion: The results of analysis have been validated as per International Conference on Harmonization (ICH) guidelines. The developed method can be adopted in routine analysis of Dapagliflozin in bulk and tablet dosage form. The Proposed method was found to be rapid, accurate, precise, specific, robust, rugged and economical.