1Department of Pharmaceutics, Pravara Rural Education Society, College of Pharmacy (For Women's), Chincholi, Nashik, Maharashtra, India 422102
2Department of Pharmaceutics, Pravara Rural Education Society College of Pharmacy (For Women's), Chincholi, Nashik, Maharashtra, India 422102
3Department of Pharmacology, Pravara Rural Education Society College of Pharmacy (For Women's), Chincholi, Nashik, Maharashtra, India 422102
4Department of Quality Assurance, Pravara Rural Education Society College of Pharmacy (For Women's), Chincholi, Nashik, Maharashtra, India 422102
*Corresponding Author
Background: Ertugliflozin is an antidiabetic medication that belongs to the class of Sodium-Glucose Cotransporter-2 inhibitors. Ertugliflozin is mainly employed to reduce elevated blood glucose levels.
Objective: The aim of the current study is to establish a reliable, precise, and validated bioanalytical method for quantifying Ertugliflozin in human plasma using reverse-phase high-performance liquid chromatography.
Materials & Methods: Chromatographic analysis was performed at 239 nm on a Thermo C18 column (150 mm × 4.6 mm, 5 μm) using an optimized method. The flow rate was 0.9 mL/min, using a methanol:0.1% GAA (75:25% v/v) mixture at pH 3, with 1 mL of plasma as the mobile phase. The method underwent validation for its linearity, accuracy, precision, and robustness, following the standards outlined in the ICH guidelines. The validated method was then used to determine the marketed formulation in plasma.
Results: Among six trials, the optimized method showed a sharp peak. Chromatographic parameters included a retention time of 3.872 minutes, 5931 theoretical plates, a tailing factor of 0.94, and a resolution of 2.5. A linear response was observed over the concentration range of 2 to 10 µg/ml, with a correlation coefficient of 0.9992, indicating excellent linearity. Recovery studies at three concentration levels showed 99.39% at 80%, 99.25% at 100%, and 99.58% at 120%, all with RSD less than 2%. This indicated good accuracy. LOD and LOQ were 2.1782 μg/mL and 0.7188 µg/mL, respectively. The estimation of EFG in the marketed formulation was 99.25%.
Conclusion: The developed RP-HPLC method was validated and is suitable for routine quantification of drugs in biological samples.
Keywords: Ertugliflozin, RP-HPLC, Bioanalytical Method Validation, Human Plasma
How to cite this article: Kedar PB, Gaware VM, Kunde VD, Gaikar MT, Dhamak KB. Bio-Analytical Method Development and Validation for Estimation of Ertugliflozin by RP-HPLC in Dosage Form. Int J Drug Deliv Technol. 2026;16(14s): 255. DOI: 10.25258/ijddt.16.14s.30
Source of support: Nil.
Conflict of interest: None