Method Development, Optimization And Validation For Simultaneous Estimation Of Dapagliflozin And Bisoprolol In Active Pharmaceutical Ingredient And Pharmaceutical Dosage Form By RP-HPLC Method
Year: 2026
Type: article
Abstract: Background: Simultaneous quantitative analysis of combination drug products requires a chromatographic procedure capable of providing adequate separation, reproducible response and acceptable analytical performance. Reverse-phase high-performance liquid chromatography (RP-HPLC) is widely used for pharmaceutical assay because of its versatility and compatibility with UV detection. Objective: The present study aimed to develop, optimize and validate a simple, accurate, precise, robust and cost-effective isocratic RP-HPLC method for simultaneous estimation of dapagliflozin and bisoprolol in bulk drug and tablet dosage form. Methods: Separation was developed on a C18 column (250 × 4.6 mm i.d., 5 µm) using methanol and citric-acid buffer as the mobile phase at a reported ratio of 64:36% v/v, a flow rate of 1.0 mL/min and UV detection at 227 nm. Standard and tablet sample solutions were prepared and the method was evaluated for specificity, linearity, precision, accuracy, robustness, ruggedness, limit of detection (LOD) and limit of quantification (LOQ). Results: The optimized method produced reported retention times of approximately 2.86 min for dapagliflozin and 14.20 min for bisoprolol. The thesis reports linearity over 10–30 µg/mL for dapagliflozin and 5–25 µg/mL for bisoprolol, with correlation coefficients of 0.9995 and 0.9992, respectively. Interday % RSD was 1.007% and 0.08872%, while intraday % RSD was 0.2694% and 0.3349% for dapagliflozin and bisoprolol, respectively.Mean recovery was approximately 99–101%. Assay of Gluxit Beta 5 was 99.39% for dapagliflozin and 100.68% for bisoprolol. Conclusion: The reported findings support the suitability of the developed isocratic RP-HPLC procedure for routine assay of dapagliflozin and bisoprolol in the investigated bulk and tablet samples. Before journal submission, the pH, bisoprolol linearity range, regression data and LOD/LOQ values should be checked against the original laboratory calculation sheets because the source thesis contains internal inconsistencies.
Language: English
Subfield: Analytical Chemistry
Field: Chemistry
Domain: Physical Sciences
Open Access status: green
OpenAlex ID: W7220984860