Assay Method for Quality Control and Stability Studies of a New Antidiabetic Agent (S-001-469)

Abstract

In the present study, for the first time, HPLC method of CDRI compound S-001-469 is reported, S-001-469 is a new potential substituted chalcone based antidiabetic candidate drug under preclinical development phase. The current study illustrates comprehensive stress testing of S-001-469 under different prescribed ICH stress conditions. A reverse phase high performance liquid chromatographic (HPLC) assay method for determination of S-001-469 with its starting materials, intermediates and degradation product has been developed and validated for in process quality control and stability studies. The analytical performance parameters such as linearity, precision, accuracy, specificity, limit of detection (LOD) and lower limit of quantification (LLOQ) were determined according to International Conference on Harmonization guidelines. Compound S-001-469 was subjected to acidic, alkaline, oxidative (H2O2 and photolytic degradations. HPLC separation was achieved on SunFire™ C-18 column (250 mm, 4.6 mm, 5 m, Waters) using a mobile phase consisting of acetonitrile-0.01 M sodium acetate buffer (pH 4.75) (60:40, v/v) at a flow rate of 1 ml/min and the eluents were monitored by photo diode array detector at 360 nm. Based on signal to noise ratio of 3 and 10 the LOD of S001 469 was 0.98 g/ml, while the LLOQ was 3.9 g/ml. The calibration curve was linear in the range of 3.9–125 g/ml.