1Department of Quality Assurance, K. B. Raval College of Pharmacy, Kasturinagar, Shertha, Gandhinagar, Gujarat, India
2Department of Quality Assurance, S. K. Patel College of Pharmaceutical Education and Research, Ganpat University, Kherva, Gujarat, India
A newer simple, reproducible and cost efficient RP-HPLC method has been developed and validated for the determination of Remogliflozin in bulk and its pharmaceutical Dosage Form. Analytical Quality By Design Approach was applied for the determination of Remogliflozin in which Agilent 1220 infinity II, ODS C18 Column was used for the proposed work. Initial risk assessment was performed for identification of Critical Analytical Parameters and Amount of Acetonitrile, Flow Rate and pH were selected as CAA. ACN: KH2PO4 Buffer pH 5(50:50% v/v) was selected as a mobile phase after applying AQbD approach. The flow rate was 1ml/min and 229nm was used to analyze Remogliflozin. The correlation coefficient was found to be 0.9995 for Remogliflozin. The developed method was validated as per ICH guideline.
Remogliflozin, RP-HPLC, Quality by design, ICH
