REVERSE PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR SEPARATION AND ESTIMATION OF IMPURITIES PRESENT IN PHARMACEUTICAL FORMULATION OF CANAGLIFOZINAbstract
Canagliflozin is sodium-glucose co-transporter-2 inhibitors work by inhibiting SGLT2 to prevent reabsorption of glucose and facilitate its excretion in urine. Impurities in pharmaceuticals which are unwanted chemicals that remain with the active pharmaceutical ingredients (APIs), or develop during stability testing, or develop during formulation or upon aging of both API and formulation. The presence of these unwanted chemicals, even in small amounts, may influence the efficacy and safety of the pharmaceutical products. A simple and very sensitive method developed for estimation of impurities present in Canaglifozin formulation by Reverse Phase High Performance Liquid Chromatographic method. A method is capable to detect impurities at very low level (0.1 µm/mL). Chromatographic separation of six different impurities was achieved on inertsil C8-3 (250 × 4.6) mm, 3 µm column using gradient elution method.
N. Patel * and S. Patel
Department of Quality Assurance, Shree S. K. Patel College of Pharmaceutical Education and Research, Ganpat University, Ganpat Vidhyanagar, Gujarat, India.
11 July 2019
26 November 2020
17 April 2020
01 June 2020