Development and Validation of a Stability-Indicating HPLC-DAD Method for the Determination of Canagliflozin and Metformin Simultaneously in Combination Dosage Form

• Published in: Pharmaceutical chemistry journal Vol. 55; no. 4; pp. 402 - 409
• Main Authors: Al-Shdefat, Ramadan, Al-Ani, Israa, Tamimi, Lina, Awad, Riad, Rayyan, Walid Abu, Dayyih, Wael Abu
• Format: Journal Article
• Language: English
• Published: New York Springer US 01.07.2021; Springer
• Subjects: Analysis; High performance liquid chromatography; Medicine; Metformin; Methanol; Methods; Organic Chemistry; Pharmacology/Toxicology; Pharmacy; Type 2 diabetes; stability- indicating method; development; HPLC-DAD; canagliflozin; metformin; forced degradation; tablets; validation
• ISSN: 0091-150X; 1573-9031
• DOI: 10.1007/s11094-021-02436-7

The purpose of this study was to develop and validate a rapid, simple, easy, and precise high-performance liquid chromatography (HPLC) method with diode array detector (DAD) for the simultaneous determination of canagliflozin (CGLN) and metformin (MTFN) in a combined dosage formulation. The chromatographic separation was achieved using a column type Zorbax-x Sβ-C18 (4.6 × 250 mm, 5 μm particle size). Mobile phase consisted of 0.05 M H 3 PO 4 , acetonitrile, and methanol in the 45:45:10 (v/v) ratio. The method was validated as per ICH guidelines in terms of system suitability, ranges, linearity, precision, specificity, accuracy, robustness, limit of quantification (LOQ) and limit of detection (LOD). The retention time (RT, t r ) for MTFN and CGLN were obtained at 8 and 9.45 min, respectively. The calibration curves were found linear in the range of 5 – 100 μg/mL for both drugs in this study, with good correlation coefficients ( R 2 > 0.99898). The suggested design proved to be selective and stability-indicating by the resolution ( R s ) of both analytes as well as by the study of forced-degradation (hydrolysis, oxidation, photolysis, and dry heat) products. The validated HPLC-DAD procedure was profitably tested for the analysis of CGLN and MTFN in their combination pharmaceutical tablet dosage form. In conclusion, a simple selective HPLC-DAD method has been successfully developed and validated for the determination of CGLN and MTFN simultaneously in pharmaceutical dosage form.