• S. Vineesha
• Dr. S. Shobha Rani
• Mahesh Rajendra Awate
• K.S.L Harika

A Specific, precise, and accurate RP-HPLC method has been developed and validated for the quantitative analysis of Dapagliflozin in tablet formulation. A Gradient separation was achieved using a X-Select HSS T3 (150mm x 4.6 mm), 3.5µm column with a flow rate of 1.2ml/min and PDA detector at 225nm. Gradient elution was performed with mobile phase-A, Buffer: Methanol (90:10% v/v) and mobile phase-B is Acetonitrile: Milli-Q water (90:10%v/v). The Diluent consists of water and Acetonitrile in the ratio of 20:80%v/v. The method was validated for specificity, linearity, precision, accuracy and robustness. The specificity of the method was determined by assessing interference from the blank, placebo, known impurities and by stress testing the drug product (forced degradation). The method was linear over the concentration range 15-150 ppm (r2 = 1.0). The accuracy of the method was between 98.8-101.4%. The method was found to be Robust and suitable for the quantitative analysis of Dapagliflozin in a tablet formulation. Degradation products resulting from the stress studies did not interfere with the detection of Dapagliflozin peak in chromatogram, demonstrating the stability-indicating method.

Stability indicating method, RP-HPLC, Gradient Technique

"Stability Indicating Assay Method Development And Validation Of Dapagliflozin In Pharmaceutical Dosage Form By RP-HPLC", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.5, Issue 11, page no.161-170, November-2018, Available :http://www.jetir.org/papers/JETIR1811A23.pdf

"Stability Indicating Assay Method Development And Validation Of Dapagliflozin In Pharmaceutical Dosage Form By RP-HPLC", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.5, Issue 11, page no. pp161-170, November-2018, Available at : http://www.jetir.org/papers/JETIR1811A23.pdf