Development and Validation of RP-HPLC Method for Determination of Antidiabetic Drug (Imeglimin HCL) in Bulk and its Dosage Form.

Abstract

Background: Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) is used to analyse the Imeglimin hydrochloride (HCL). Accurate and precise analytical methods are crucial for the pharmaceutical analysis of imeglimin HCL, a novel antidiabetic pharmaceutical with promising therapeutic effects.

Objective: To Optimize chromatographic conditions including mobile phase composition, column type, and detection wavelength to achieve good resolution, sensitivity, and selectivity for imeglimin. To Validate the developed RP-HPLC method according to international guidelines (e.g., ICH guidelines).

Method: The method was developed by using Phenomenox, C18 (250 mm X 4.6 mm, 5 µm) column. The mobile phase was adjusted to achieve the highest possible resolution, sensitivity, and peak symmetry. It contains methanol at 0.05 percent TFAA in water at 20% V/V. At a flow rate of 1.0 millimetres / minute, the detection was carried out at 240 nm. The developed method was validated according to ICH guidelines.

Result: To assess the method's performance and reliability, it was validated according to International Conference on Harmonization, or ICH, standards. Specificity, linearity, precision, accuracy, robustness, and system the suitability all within the validation parameters. Imeglimin HCL's linearity was between 1.0 - 15 µg/ml. Imeglimin HCL showed a mean recovery of 99.36%.

Conclusion: Imeglimin HCL in pharmaceutical formulations was successfully evaluated employing the authorized RP-HPLC method, showing the method's suitability for routine quality control. The pharmaceutical industry has a useful tool to ensure the efficacy and quality of formulations containing imeglimin HCL as a result of the suggested method.