Development and Validation of a Stability-Indicating RP-HPLC Method for Simultaneous Estimation of Dapagliflozin and Metformin
Year: 2026
Type: article
Abstract: A rapid, precise, and stability-indicating reverse phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for the simultaneous estimation of Dapagliflozin and Metformin in bulk and pharmaceutical dosage forms. Chromatographic separation was achieved using a C18 column (250 mm × 4.6 mm, 5 µm) with a mobile phase comprising acetonitrile and 20 mM ammonium formate buffer (pH 3.5) in the ratio of 40:60 (v/v) under isocratic conditions, with a flow rate of 1.0 mL/min and detection at 245 nm. The method provided well-resolved peaks with retention times of 3.30 min for Dapagliflozin and 5.00 min for Metformin, ensuring a short analysis time with excellent resolution. The calibration curves exhibited excellent linearity over concentration ranges of 2–20 µg/mL (R2 = 0.9992) for Dapagliflozin and 10–100 µg/mL (R2 = 0.9995) for Metformin. Accuracy studies showed recovery values within 99.52–101.36% and 99.86–100.48%, respectively, while precision was confirmed with %RSD values below 2%, indicating good repeatability and reproducibility. The method demonstrated high sensitivity with LOD values of 0.42 µg/mL and 2.05 µg/mL, and LOQ values of 1.26 µg/mL and 6.20 µg/mL for Dapagliflozin and Metformin, respectively. Robustness studies indicated that minor variations in analytical conditions did not significantly affect the method performance. The method was successfully applied to marketed formulations, yielding assay values within 99–101%. Forced degradation studies under acidic, alkaline, oxidative, thermal, and photolytic conditions confirmed the stability-indicating capability of the method, as no interference from degradation products was observed. The developed method is simple, rapid, accurate, and suitable for routine quality control and stability analysis.
Language: English
Subfield: Analytical Chemistry
Field: Chemistry
Domain: Physical Sciences
Open Access status: bronze
OpenAlex ID: W7161970678