ArticleACS omega2023
Analytical Quality by Design-Assisted HPLC Method for Quantification of Canagliflozin and Stability Studies.
Article in ACS omega, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
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Who cites it
6 citing papers in PubMed, 14 citations in OpenAlex.
- Stability-Indicating HPLC Method for Simultaneous Determination of Sulfadimethoxine and Ormetoprim in an Oral Solution.ACS omega · 2026Article
- Oral Antidiabetic Agents: From Routine Quality Control to Bioanalysis.Molecules (Basel, Switzerland) · 2026Review
- Development and Optimisation of a Stability-Indicating Analytical Method for Itraconazole in Drug Product by High-Performance Liquid Chromatography Using a QbD Approach.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Green RP-HPLC method for estimation of trigonelline: AQbD based development, validation, and application to nanoformulations.BMC chemistry · 2026Article
- Simultaneous estimation of finerenone and canagliflozin using HPLC: application in metabolic stability studies.Bioanalysis · 2025Article
- Article
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Authors and funding
2 authors at 1 institution in 1 country.
Funding
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Abstract
The present study is intended to develop the high-performance liquid chromatography (HPLC) method for the analysis of Canagliflozin using the analytical quality by design (AQbD) approach. The key parameters were methodically optimized with the help of factorial experimental design, and contours were plotted when investigated using Design Expert software. A stability-indicating HPLC technique was developed and validated for the quantitative estimation of Canagliflozin, and its stability was assessed using various forced degradation conditions. Successful separation of Canagliflozin was accomplished using a Waters HPLC system with a photo diode array (PDA) detector and Supelcosil C18 column (250 × 4.6 mm, 5 μm) and 0.2% v/v solution of trifluoroacetic acid in water/acetonitrile (80:20% v/v) as the mobile phase maintaining the flow rate at 1.0 mL/min. The detection wavelength was 290 nm, and Canagliflozin got eluted at 6.9 min with a run time of 15 min. Canagliflozin peak purity values in all degradation conditions indicated that the peak is homogeneous, and therefore this method can be considered stability-indicating. The proposed technique was found to be specific, precise (% RSD about 0.66%), linear (12.6-37.9 μg/mL), rugged (overall % RSD about 0.50%), and robust. The standard and sample solutions were stable after 48 h (cumulative % RSD about 0.61%). The developed AQbD-based HPLC method can be used for the assay of Canagliflozin in Canagliflozin tablets of regular production batches and stability samples.
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Registered trials
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