Shailesh G. Jawarkar

Artesunate (1) (ART), also called as dihydroartemisinin-12-α-succinate, it is a semisynthetic peroxide-bridged sesquiterpene lactone compound derived from Artemisinin, the bioactive component of the Chinese medicinal herb called Artemisia annua.  An accurate, simple and precise HPLC method was developed and validated for forced degradation studies of drug Artesunate .The column was used C18 column (150X4.6mmX5µm ) column  by isocratic elution. The mobile phase composition consisted of Acetonitrile Water and trifluoroacetic acid (TFA) in the ratio of 55:45:0.1 v/v. The analysis was performed at a 1ml/min flow rate. The analytical performance parameters such as linearity, precision, accuracy, specificity, limit of detection (LOD) and lower limit of quantification (LOQ) were determined according to International Conference for Harmonization ICH Q2 (R1) guidelines.

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.