Development and Validation Of RP-HPLC Method for Dapagliflozin and Bisoprolol In Bulk and Pharmaceutical Dosage Form
Year: 2026
Type: article
Abstract: The simultaneous quantification of antidiabetic and cardiovascular drugs is essential for patients with comorbid conditions, where polypharmacy is common. In this study, a novel HPLC method was developed and validated for the determination of Dapagliflozin (a sodium-glucose co-transporter 2 inhibitor) and Bisoprolol (a β1-selective adrenergic blocker) in pharmaceutical dosage forms. Method development was guided by the physicochemical properties of the analytes, employing a C18 column (250 × 4.6 mm, 5 µm) with a mobile phase consisting of methanol and phosphate buffer (60:40, pH 3.8). Chromatographic separation was achieved within a short run time of 10 minutes, with Dapagliflozin eluting at 2.99 minutes and Bisoprolol at 3.64 minutes, ensuring efficient throughput. Peaks were sharp, symmetrical, and well resolved, with resolution values exceeding 2.0, confirming baseline separation and system suitability. The method demonstrated excellent linearity across the range of 5–100 ng/mL, with correlation coefficients of 0.998 and 0.999, respectively. The limits of detection (LOD) and limits of quantification (LOQ) were approximately 1 ng/mL and 3 ng/mL, highlighting the method’s sensitivity. Validation studies confirmed compliance with ICH Q2(R2) guidelines (2023). Accuracy was established with recovery values between 98–102%, while precision studies showed %RSD values below 2.0% for both intra-day and inter-day analyses. Robustness testing indicated that minor variations in mobile phase composition and flow rate did not significantly affect retention times or peak areas, underscoring the stability of the method. Specificity was confirmed by the absence of interfering peaks in blank and placebo samples. In conclusion, the developed method is rapid, sensitive, accurate, precise, and robust, making it suitable for routine quality control of bulk drugs and dosage forms. Its high sensitivity and selectivity also suggest potential applications in bioanalytical studies, including pharmacokinetic profiling and therapeutic drug monitoring, thereby contributing to pharmaceutical quality assurance and clinical research.
Language: English
Subfield: Analytical Chemistry
Field: Chemistry
Domain: Physical Sciences
Open Access status: green
OpenAlex ID: W7154562448