• Namrata D Mahajan
• JeejaPananchery
• Dr Ashish jain

A simple, accurate, sensitive RP-HPLC method was developed for the determination of Dapagliflozin in bulk and it’sfilm coated tablet dosage form. The chromatographic separation was achieved on a reverse phase C18 Peerless Basic Column (250 mm×4.6 mm×5 μm). The mobile phase system consisting of acetonitrile and water (90:10v/v), was pumped using isocratic mode at 1mL/min flow rate. Detection of drug was made spectrophotometrically at a wavelength 223 nm using PDA detector and column temperature was adjusted at 30℃. The retention time was found to be 3.30 min. The method was validated to fulfil International Council on Harmonization (ICH) requirements and included specificity, linearity, precision, accuracy, limit of detection (LOD), limit of quantification (LOQ), robustness. The analyte response was instituted to be linear from range 10-60 μg/ml with a regression value of 0.997. % recovery was obtained as 100.59%, 100.45%, 101.29%. Limit of Detection and Limit of Quantification was found to be 2.91 μg/ml and 8.92 μg/ml. The method was found statistically accurate, precise with relative standard deviation (%RSD) values <2.0% and robust. Thus, proposed method is convenient, efficient and useful in routine analysis for estimation of Dapagliflozin in its bulk form and film coated tablet dosage form. Index Terms: Dapagliflozin, Method Development and Validation, RP-HPLC.

"REVERSE PHASE HIGH PRESSURE LIQUID CHROMATOGRAPHIC METHOD DEVELOPMENT AND VALIDATION OF DAPAGLIFLOZIN IN BULK AND SOLID DOSAGE FORM", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.12, Issue 9, page no.e297-e306, September-2025, Available :http://www.jetir.org/papers/JETIR2509432.pdf

"REVERSE PHASE HIGH PRESSURE LIQUID CHROMATOGRAPHIC METHOD DEVELOPMENT AND VALIDATION OF DAPAGLIFLOZIN IN BULK AND SOLID DOSAGE FORM", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.12, Issue 9, page no. ppe297-e306, September-2025, Available at : http://www.jetir.org/papers/JETIR2509432.pdf