Development and Validation of HPLC Method for Determination of an API in Presence of its Degradation Products

The present study describes the development and validation of HPLC (HILIC) method for determination of an Imeglimin in presence of its degradation products. The proposed HPLC method utilizes a new HILIC for the determination of Imeglimin. The separation was achieved by using ZIC-HILIC (5µm; 150 x 4.6 mm ID.column by using solvent A; 15mM ammonium acetate solvent B; acetonitrile (50:50, v/v) as mobile phase with the flow rate of 1ml/min. Where detection was carried out by UV detector (SPD-10AVP) at 230nm. The retention time was found to be 5.138min. The described method was linear over the range of 1.56 –50 µg/ml. 1.56 –50 µg/ml . The mean regression equation was found to be y= 336299x + 344398 , R 2 = 0.9997. The precision, ruggedness, accuracy, repeatability, robustness values were also within the prescribed limits. Imeglimin was exposed to acidic, basic, oxidative, thermal, photo degradation and stressed samples were analysed by the proposed method. Chromatographic peak purity results indicated the absence of co-eluting peaks with the main peak of Imeglimin, which demonstrated the specificity of method for estimation of Imeglimin in presence of degradation products. The proposed method can be used for routine analysis of Imeglimin.