TY  - JOUR
T1  - UV-Spectrophotometric Method Development and Validation for Quantifying Dapagliflozin in Bulk and Pharmaceutical Formulations
A1  - Saipranavi Vadla
A1  - Vaishnavi Putta
A1  - Saipriya Nadipudi
A1  - Sowmaya Bilakanti
A1  - Neelima Kudumula
JF  - Pharmaceutical Sciences and Drug Design
JO  - Pharm Sci Drug Des
SN  - 3062-4428
Y1  - 2023
VL  - 3
IS  - 1
DO  - 10.51847/r8kjhgT7Qr
SP  - 31
EP  - 38
N2  - This research focused on establishing a new and highly sensitive UV-spectrophotometric approach for quantifying dapagliflozin in tablet dosage form while ensuring comprehensive validation of analytical parameters following ICH guidelines. The maximum absorbance (λmax) of dapagliflozin was identified at 220 nm using a UV-Vis spectrophotometer equipped with a 1 cm quartz cell. A stock solution of 1000 μg/ml was prepared using a solvent system consisting of methanol and water in a ratio of 15:85, and subsequent dilutions were performed using distilled water to obtain working solutions. The analytical method adhered to Beer’s Lambert’s law across a concentration range of 5–30 µg/ml, yielding a correlation coefficient of 0.999. Sensitivity parameters included a limit of detection (LOD) of 0.623 µg/ml and a limit of quantification (LOQ) of 1.889 µg/ml. The estimated drug content was approximately 103%, aligning well with the labeled claim of the marketed formulation (Udapa*10). Recovery studies were performed at three different levels, which showed satisfactory results. Furthermore, robustness and ruggedness evaluations showed that the method remained within acceptable limits. Given its simplicity, cost-effectiveness, and reliability, this method is well-suited for routine quantitative assessment of dapagliflozin in bulk and commercial pharmaceutical products.
UR  - https://galaxypub.co/article/uv-spectrophotometric-method-development-and-validation-for-quantifying-dapagliflozin-in-bulk-and-ph-af3j9igmybgd73f
ER  -