Stability studies

The present study describes the development and subsequent validation of Reverse phase HPLC (RP-HPLC) method for the analysis of Imeglimin hydrochloride. A novel economic, simple, rapid, accurate, reproducible, and precise Reverse Phase High Performance Liquid Chromatography (RP-HPLC) method for Imeglimin hydrochloride. The method was performed on a YOUNG LIN-HPLC system-ACME9000. The method developed for Imeglimin hydrochloride was quantitatively measured using an isocratic RP-HPLC methodology. The chromatographic separation of Imeglimin hydrochloride was achieved on RP-HPLC equipped with Hypersil BDS C18 (250mm x 4.6mm, 5 um) column using isocratic elution with a mobile phase consisting of MeOH: Buffer in a ratio of (70:30% v/v) at a flow rate of 1.0ml/min with an injection volume of 20µl, where detection was carried out by UV- 730D detector at 239nm The retention time for Imeglimin hydrochloride was found to be 3.47 min. The developed method was successfully with results falling within acceptable criteria validated for different validation parameters as per (ICH-Q2 (R1)) guidelines. The linear regression equation was found to be y = 27.83x - 8.512 with a correlation coefficient (R2) > 0.999 which shows excellent linear correlation. Accuracy, precision, specificity, system suitability, robustness, linearity, LOD and LOQ were determined for method validation. The results were found to be well within recommended limits as per ICH guidelines. Stability studies of Imeglimin hydrochloride were carried out under acidic, basic, peroxide, photolytic and thermal conditions. Degradation was observed in acidic, basic, and oxidative conditions, but not in photolytic and thermal conditions.  

  High-performance liquid-chromatography method was developed and validated for the determination of impurities (Related Substances) of Mycophenolate mofetil in tablets and capsules using Photo diode array detector. The mobile phase was a combination of Triethylamine buffer (pH 5.3) and acetonitrile in the ratio of 65:35 and wavelength set at 250 nm. Retention time of Mycophenolate mofetil and its impurity as Mycophenolic acid was found to be approx. 21.31 and 5.79 minutes respectively. Linearity of the method for Mycophenolate mofetil and its impurity as Mycophenolic acid was found to be 0.4 to 24.163 μg mL-1 with the correlation coefficient of 1.000 and 0.9999 respectively. This method was validated accordingly to International Conference of Harmonization guidelines. Qualification was alone by calculating area of the peaks and peak purities. The analytical solution of Mycophenolate mofetil also has shown stability for 24 hrs at 5°C and 25°C. Present method can be applied for the impurity profiling and stability studies of Mycophenolate mofetil in tablet and capsules formulations without interference of the excipients present in the particular formulations