Development and Validation of a Robust UPLC Method for the Concurrent Determination of Metformin and Canagliflozin in Combined Tablet Dosage Forms

Background: Because of the complimentary ways in which Metformin and Canagliflozin work together, fixed-dose combination pills are frequently used to treat type 2 diabetes mellitus. For routine quality control of such formulations, a rapid, reliable, and sensitive analytical method is required.  Aim and Objective: In compliance with ICH recommendations, the current work sought to create and validate a straightforward, accurate, precise, and robust Ultra Performance Liquid Chromatography (UPLC) method for the simultaneous estimation of metformin and canagliflozin in tablet dose form.  Methods: Using a mobile phase of phosphate buffer (pH 3.0) and acetonitrile (60:40, v/v) at a flow rate of 0.3 mL/min, chromatographic separation was accomplished on a C18 column. UV detection was carried out at 230 nm for metformin and 264 nm for cnagliflozin. The method was validated for specificity, linearity, accuracy, precision, limit of detection (LOD), limit of quantification (LOQ), and robustness.  Results and Discussion: Metformin and Canagliflozin were well separated with retention times of approximately 2.10 min and 3.53 min, respectively, and a resolution greater than 3.0. The method showed excellent linearity in the concentration ranges of 10– 100 µg/mL for Metformin and 1–20 µg/mL for Canagliflozin with correlation coefficients (r²) of 0.999 and 0.999, respectively. Precision studies showed %RSD values below 1%, indicating good repeatability. Accuracy studies yielded recoveries in the range of 99.0–100.8% for Metformin and 99.0–100.6% for Canagliflozin. The LOD and LOQ were found to be 0.12 and 0.36 µg/mL for Metformin and 0.2 and 0.73 µg/mL for Canagliflozin, respectively, demonstrating good sensitivity. Assay of the marketed tablet formulation showed drug content of 99.7% for Metformin and 101.2% for Canagliflozin.  Conclusion and Outcome: The developed UPLC method is simple, rapid, accurate, precise, and sensitive, and is suitable for routine quality control analysis of Metformin and Canagliflozin in combined tablet dosage forms.