Stability Indicating Method Development of Metformin, Teneligliptin and Pioglitazonein Marketed Formulation by HPLC
Expansion and validation of a stability-indicating HPLC approach allowed one to simultaneously test metformin (MET), teneligliptin (TNG), and pioglitazone (PGL) in their commercially available pharmaceutical forms. Techniques were developed to detect active pharmaceutical ingredients (APIs) and any degradation byproducts in settings either acidic, alkaline, oxidative, or photolytic. To evaluate the stability of MET, TNG, and PGL and make sure the technique could extract the medications from their breakdown products, forced degradation studies were conceded out. The ICH guiding principle followed in validation of method. The outcomes demonstrated that the developed method could accurately and sensitively identify and measure the drugs and the products of their degradation. Under stress, formed degradation products were excellently isolated and measured; therefore, method was found to be robust in several conditions. This stability-indicating HPLC methodology useful for repetitive quality control and stability analysis of MET, TNG, and PGL in pharmaceutical formulations.
Authors
- Neelam Singla (ORCID: https://orcid.org/0000-0002-3583-7025)
- Parvin Ahamad Shaikh
Publication Details
- Journal
- International Journal of Drug Delivery Technology
- Published
- 2025-03-25
- DOI
- https://doi.org/10.25258/ijddt.15.1.41
- Citations
- 1
- Primary Topic
- Analytical Chemistry and Chromatography
- Type
- article
- Field-Weighted Citation Impact
- 0.76