Greenness assessment and stability-indicating HPTLC method for the concurrent analysis of dapagliflozin propanediol monohydrate and bisoprolol fumarate in a novel combined oral formulation

This study involved the development and validation of a precise and reliable HPTLC method for the concurrent analysis of Dapagliflozin propanediol monohydrate and bisoprolol fumarate in pharmaceutical formulations. adhering to the Q2(R2) guidelines established by the International Council for Harmonization. Chromatographic separation was achieved on HPTLC silica gel 60 F₂₅₄ plates (10.0 cm × 10.0 cm, 0.20 mm) with a mobile phase of Chloroform: Toluene: Methanol: Ammonia (1:2:6:0.1 v/v/v). Detection was performed at 224 nm. Retention factor (Rf) values for Dapagliflozin propanediol monohydrate and bisoprolol fumarate were 0.22 ± 0.003 and 0.63 ± 0.006, respectively. The method showed excellent linearity with correlation coefficients of 0.9995 and 0.9991 for Dapagliflozin (200–1200 ng/band) and bisoprolol fumarate (100–600 ng/band), respectively. The reported method demonstrated precision in both intraday and interday analyses, with the percentage relative standard deviation of the peak area remaining below 2%. and recovery studies confirmed high accuracy with values ranging from 98.21 to 100.08% for dapagliflozin and 99.19–100.15% for bisoprolol fumarate. Forced degradation studies revealed that dapagliflozin was more susceptible to acidic and oxidative hydrolysis compared to bisoprolol fumarate, with baseline-resolved degradation products observed in all stress conditions. The developed HPTLC method has potential application for the concurrent quantification of Dapagliflozin propanediol monohydrate and bisoprolol fumarate in formulation. The MoGAPI tool and its associated software constitute a significant advancement in the assessment of analytical method greenness, offering researchers a robust and user-friendly platform for the evaluation and comparison of analytical techniques.