RP-HPLC TECHNIQUE FOR SIMULTANEOUS ESTIMATION OF REMOGLIFLOZIN AND METFORMIN IN BULK AND FORMULATION

The most common and powerful approach for drug analysis is high-performance liquid chromatography. The current study focuses on the development and validation of innovative RP-HPLC analytical techniques for the development of drug contents in solid oral dosage forms. In the therapeutic drug monitoring and pharmaceutical sectors, method development is critical. It is always preferable to choose and develop a method for determining pharmaceuticals in pharmaceutical dosage forms and biological fluid samples that is straightforward, accurate, exact, and cost-effective. In the discovery, development, and production of drugs and pharmaceuticals, analytical method development and validation are critical. The new simple, novel, precise, rapid, reliable, accurate, and reproducible reverse-phase high-performance liquid chromatography (RP-HPLC) technique for simultaneous estimation of Remogliflozin and Metformin in bulk and formulation. The separation was achieved using ODS, C18 (250 mm × 4.6 mm, i.d.2.5 µm) column with isocratic elution. A mixture of acetonitrile: 20 mM ammonium formate buffer (pH 3.5) at the ratio of (60:40) as a mobile phase with a flow rate of 1.0 ml min-1 was used for the separation of analytes. The separated effluents were monitored with a diode array detector at 243 nm. The results showed good linearity over a range of 2.5–25 μg ml-1 and 12.5–125 μg ml-1 for Remogliflozin and Metformin respectively. Furthermore, the average percentage assay of marketed formulations of Remogliflozin and Metformin was found to be 100.30% and 100.52 %, respectively. Remogliflozin limit of detection (LOD) and limit of quantitation (LOQ) were 0.42 and 1.28 μg ml-1while LOD and LOQ for Metformin were 1.97 and 5.96 μg ml-1 respectively. Keywords: Remogliflozin, Metformin, Simultaneous estimation, Method development, ICH, RP-HPLC.