STABILITY INDICATING TLC METHOD FOR THE DETERMINATION OF ROSUVASTATIN AND IDENTIFICATION OF SOME DEGRADATION PRODUCTS USING ELECTROSPRAY IONIZATION MASS SPECTROMETRY

摘要: A validated stability indicating thin layer chromatographic (TLC) method was developed to analyze rosuvastatin calcium (ROS) and its degradation products (DPs). All stress conditions recommended by the international conference on harmonization (ICH) including oxidative, photolytic, thermal, acidic, basic hydrolysis were applied. ROS DPs selectively separated using aluminum plates precoated with silica gel 60 F254 as a stationary phase chloroform: n-hexane:methanol:glacial acetic acid (8:10.4:1.5:0.1 v/v/v/v) developing system. found be highly sensitive photolysis oxidation less extent acidic hydrolysis. The chemical structures of major characterized LC-ESI-MS where two them proposed optical isomer lactone form ROS. peak area scanned spots concentration correlated polynomial regression equation in range 0.5–20 µg/spot good determination coefficient (R2 = 0.9994). lim...