Author(s):
Vidhi Dave, P. U. Patel
Email(s):
vidhidave1988@gmail.com
DOI:
10.52711/0974-360X.2025.00467 
Address:
Vidhi Dave1*, P. U. Patel2
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.
*Corresponding Author
Published In:
Volume - 18,
Issue - 7,
Year - 2025
ABSTRACT:
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.
Cite this article:
Vidhi Dave, P. U. Patel. Analytical QbD Assisted RP- HPLC Method Development and Validation for Estimation of Anti-diabetic Drug Remogliflozin in Bulk and its Pharmaceutical Dosage form. Research Journal of Pharmacy and Technology. 2025;18(7):3244-9. doi: 10.52711/0974-360X.2025.00467
Cite(Electronic):
Vidhi Dave, P. U. Patel. Analytical QbD Assisted RP- HPLC Method Development and Validation for Estimation of Anti-diabetic Drug Remogliflozin in Bulk and its Pharmaceutical Dosage form. Research Journal of Pharmacy and Technology. 2025;18(7):3244-9. doi: 10.52711/0974-360X.2025.00467 Available on: https://rjptonline.org/AbstractView.aspx?PID=2025-18-7-47
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