Research Article - Journal of RNA and Genomics (2022) Volume 0, Issue 0

Assessment of organic impurities in solid oral product of SGLT-2 inhibitors category (empagliflozin) by HPLC.

A simple and robust HPLC method for the determination &estimation of related substances of SGLT-2 Inhibitors Drug (Empagliflozin) Active pharmaceutical ingredient as well as in Marketed formulation. The chromatographic resolution achieved with different percentages of mobile phase by using ACE 5 C18 (octadecyl silane, 25 cm×4.6mm, 5.0µm column) with mobile phase composition of solvent A ( phosphate buffer & methanecarbonitrile with ratio of 92:8 %) and solvent B (phosphate buffer and ACN with ratio of 10:90 %) at a flow rate of 0.8 and Column oven temperature 30°C. The main components and its related substances eluted were estimated at 220 nm. The specificity investigated under different forced degradation conditions, mainly hydrolytic, oxidative, photolytic and thermal as recommended by ICH guidelines. The method was developed and quantified in a manner indicating the stability and the sensitivity of the drug substance.

Author(s): Krishna Mohan GV *, Konakalla Venkatesh

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