Volume 8 | Issue - 8
Volume 8 | Issue - 8
Volume 8 | Issue - 8
Volume 8 | Issue - 7
Volume 8 | Issue - 7
A new, rapid, simple, precise and accurate stability-indicating reversed phase- HPLC method has been developed and validated for quantitative determination of imeglimin hydrochloride (IMGH) in pure form and tablets. An isocratic HPLC method, using Thermo hypersile BDS C18 reversed phase column (150 mm × 4.6 mm i.d., particle size 5 μm) with isocratic mobile phase consisting of ((Methanol:(0.05 M phosphate buffer pH 3.0)) (200:800 V:V:V), was investigated to separate (IMGH) from its stress degradation products. The flow rate was 1.5 mL min-1 at temperature 30 ± 2ºC and UV detector was used at 240 nm for detection. The elution time of IMGH was found to be 2.915± 0.015 minutes. The developed method was validated for system suitability, linearity, accuracy, precision, limits of detection and quantitation, specificity, stability, robustness and for system suitability parameters as per ICH guidelines. The calibration curve was found to be linear with the equation y=298310.419x + 21402.624, with a correlation coefficient of (R2=0.99984) over a concentration range of 1.0–20 μg mL-1. The limits of detection and quantification were 0.299 and 0.907 μg mL-1, respectively. The recovery value of this method is 100.21% and the reproducibility is within 0.90%. Stability tests were done through exposure of the analyte solution for five different stress conditions: Reflux with 1.0 mol L-1 hydrochloric acid (HCl), reflux with 1.0 mol L-1 sodium hydroxide (NaOH), reflux with 30% hydrogen peroxide (H2O2), exposure to ultraviolet radiation (UV) radiation and thermal conditions. The proposed method could be used for routine analysis of IMGH in tablets