|
Development and validation of a high performance liquid chromatographic (HPLC) method for simultaneous determination of Linagliptin and Metformin in tablet
|
Melika Bagheri1    , Ensieh Ghasemi2 |
1- Department of Pharmaceutical Chemistry, TeMS.C., Islamic Azad Univeresity, Tehran, Iran
2- Associate Professor, Department of Pharmaceutical Chemistry, TeMS.C., Islamic Azad Univeresity, Tehran, Iran , ghasemi.elahe@gmail.com |
|
|
Abstract: (4 Views) |
Background: The combination of metformin, a first-line biguanide, and linagliptin, a DPP-4 inhibitor that reduces GLP and GIP degradation, improves insulin secretion, decreases glucagon production, and effectively controls blood glucose and HbA1c levels in patients with type diabetes. This study aimed to develop and validate a simple, rapid, accurate, and sensitive method for the simultaneous determination of metformin and linagliptin in tablet dosage forms.
Materials and methods: Simultaneous analysis was performed using ion chromatography with sodium lauryl sulfate as an ionic reagent. Chromatographic conditions were optimized. Peak separation and symmetry were evaluated using resolution and tailing factors. The method was validated for specificity, linearity, accuracy, precision, repeatability, detection limit, quantification limit, and robustness.
Results: Optimal separation was achieved using a C18 column (4.6 × 150 mm, 5 µm) with a mobile phase of methanol: acetonitrile: 0/02 M potassium hydrogen phosphate (10:35:55, pH 4.6), at 218 nm and a flow rate of 1 mL/min. Linearity was observed for metformin (0.11–0.66 µg/mL) and linagliptin (0.00054–0.00324 µg/mL). Retention times were 3.7 and 2.2 minutes, respectively.
Conclusion: The validated method demonstrated satisfactory accuracy, precision, and robustness and is suitable for routine quality control analysis of metformin and linagliptin tablets. Overall, this method offers a reliable and efficient analytical approach for the simultaneous determination of both drugs in combined pharmaceutical formulations.
|
|
| Keywords: Metformin, Linagliptin, Liquid chromatography, Ionic reagent, Development and validation method. |
|
|
Full-Text [PDF 1039 kb]
(1 Downloads)
|
Semi-pilot: Experimental |
Subject:
Chemistry
Received: 2025/11/15 | Accepted: 2026/01/11 | Published: 2026/09/1
|
|
|
|
|
|
|
| Send email to the article author |
|
|
|
| Add your comments about this article |
|
|
|
