Development of Simple, Reliable, Rugged, Specific and Stability Indicating HPLC Methods for Quantification of Impurities in Dapagliflozin

R. Suresh¹*, Dr. Satyavir Singh ², K. Subhash Chander Reddy^3
1Research Scholar, Department of Science, OPJS University, Churu, Rajasthan.
²Department of Science, OPJS University, Churu, Rajasthan.
³Director Honour lab R&D, Bonthapalli, Hyderabad, Telangana.

A B S T R A C T
The aim of present research work method development and validation for the quantification of Dapaliflozin and it impurities in pharmaceutical dosage form by using HPLC. The present investigation chromatographic separation was performed by YMC Pack pro C18, 150 x 4.6 mm, 3.0 µm or equivalent column maintained flow rate at 08 ml/min. Acetonitrile and water in the ratio of (1:1)(v/v) used as diluent. The absorption of UV detection was observed at 220nm. The method was statically validated according to ICH guidelines. All the validated results are present in within the limit. The developed method was can be suggeset that routine quality control analysis of Dapagliflozin in pharmaceutical formulations.
Keywords: Thermosil C18 column, Pioglitazone and Metformin, RP-HPLC