HPLC-UV Method development for Fixed Dose Pharmaceutical Formulations: Analytical Method Development and Validation for selected Fixed-Dose Formulations Using HPLC and UV Spectroscopy

Estimation of imeglimin hydrochloride in human plasma by HPLC-UV. The estimation of drugs by RP-HPLC (reverse phase chromatography) was chosen since it is advised for use with ionic and mild to non-polar compounds. Simple, specific, and superior in terms of efficiency, stability, and reproducibility is reverse phase chromatography. For the separation of imeglimin, the C18 column 250 x 4.6 mm, 5 µm particle size was chosen. In the mobile phase, various solvent solutions were tested and combined for optimum performance. Imeglimin hydrochloride (4 µg/ml) in buffer, pH 4 for Acetonitrile: Water (70:30), a concentration range (8-40 and 0.5-4 µg/ml) displaying excellent peak and a sizable resolution level. Having the mobile phase run at 1ml/min, photodiode array detectors were used to detect both analytes at 215 nm. The method was validated in different concentration ranges in human plasma. Imeglimin inter and intra-run precision was measured at less than 3.60% and had an accuracy of less than 1.869%. imeglimin in human plasma was validated by linearity, recovery matrix, and stability. The retention time of IMEG is 4.8 minutes in plasma. Suggested method denotes that it is cost-effective