Publication: DEVELOPMENT AND VALIDATION OF AN RP-HPLC DISSOLUTION METHOD FOR SIMULTANEOUS ANALYSIS OF DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE IN EXTENDED-RELEASE TABLETS
| dc.contributor.author | TAN CHING YEE | |
| dc.date.accessioned | 2025-08-05T10:46:31Z | |
| dc.date.available | 2025-08-05T10:46:31Z | |
| dc.date.issued | 2025 | |
| dc.description.abstract | Metformin hydrochloride is one of the most conventional medications used to treat diabetes, while dapagliflozin is one of the SGLT2 pharmacological inhibitors. This study aimed to establish and validate an HPLC dissolution method for the simultaneous measurement of dapagliflozin and metformin hydrochloride in a combination extended-release tablet, in accordance with the ICH recommendations. The Xbridge C18 150 x 4.6 mm, 5 μm column, mobile phase consists of methanol and io-pairing agent buffer in gradient mode operated at 1.0 mL/min and 30oC were used to create the ideal chromatographic conditions that detect the peaks at 230 nm. The method's linearity, accuracy, precision, and robustness were demonstrated by its successful development and validation. Throughout 24 hours, both the solutions of standard and sample were stable at room temperature. In vitro dissolution profile testing in pH 1.2, 4.5 and 6.8 dissolution media using innovator drug, Xigduo XR tablet have been conducted and the results passed the dissolution specifications. The validated HPLC method as well as in vitro dissolution profile information will be useful to the generic pharmaceutical industries for product registration. | |
| dc.identifier.uri | https://hdl.handle.net/20.500.14377/37162 | |
| dc.language.iso | en | |
| dc.publisher | IMU University | |
| dc.subject | Metformin | |
| dc.subject | Chromatography, High Pressure Liquid | |
| dc.subject | Sodium-Glucose Transporter 2 Inhibitors | |
| dc.subject | Therapeutics | |
| dc.subject | Drug Liberation | |
| dc.subject | Diabetes Mellitus, Experimental | |
| dc.title | DEVELOPMENT AND VALIDATION OF AN RP-HPLC DISSOLUTION METHOD FOR SIMULTANEOUS ANALYSIS OF DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE IN EXTENDED-RELEASE TABLETS | |
| dc.type | Thesis | |
| dspace.entity.type | Publication | |
| oairecerif.author.affiliation | #PLACEHOLDER_PARENT_METADATA_VALUE# |