Editor-in-Chief
Hatice Kübra Elçioğlu
Vice Editors
Levent Kabasakal
Esra Tatar
Online ISSN
2630-6344
Publisher
Marmara University
Frequency
Bimonthly (Six issues / year)
Abbreviation
J.Res.Pharm.
Former Name
Marmara Pharmaceutical Journal
Journal of Research in Pharmacy
2023 , Vol 27 , Issue 3
Development and Validation of Stability-Indicating RPHplc Method for Simultaneous Determination of Canagliflozin and Metformin in Fixed-Dose Combination
1Department of Quality Assurance, Faculty of Pharmacy, KBC North Maharashtra University, Jalgaon, 425002, India2Department of Pharmacognosy, Faculty of Pharmacy, KBC North Maharashtra University, Jalgaon, 425002, India
3Department of Pharmaceutics, Faculty of Pharmacy, KBC North Maharashtra University, Jalgaon, 425002, India
4Department of Marketing and Sales, Torrent Pharma, Ahmedabad, 380009, India DOI : 10.29228/jrp.412 A new HPLC method has been developed and validated with different parameters for the estimation of Canagliflozin and Metformin in Fixed-Dose Combination. The chromatograms were developed using a mobile phase of Methanol: 0.1 % OPA in water (35:65) with a flow rate of 0.7 ml/min. C18 Column of 4.6 x 100 mm dimension was used as a stationary phase, particle size 5μm. The detection was carried out at 245 nm. The method was validated according to ICH guidelines for linearity, precision and Repeatability, Robustness, LOD, and LOQ. The response was found to be linear in a concentration range of 100-500 μg/ml for Metformin and 10-50 μg/mL for Canagliflozin. The stability studies of Metformin and Canagliflozin were also done through the exposure of analyte solution to different stress conditions. The developed HPLC method of Metformin and Canagliflozin was simple, precise, accurate, reproducible, and therefore suitable for routine analysis of drugs in a dosage form. Keywords : HPLC; Method Development; Method Validation; Forced degradation; Canagliflozin; Metformin