Abstract
This study was designed to establish, optimize and validate a sensitive, selective and accurate high-performance thin layer chromatographic (HPTLC) method for determination of zopiclone (ZPC) and its main impurity, 2-amino-5-chloropyridine, one of its degradation products, in raw material and pharmaceutical formulation. The proposed method was applied for analysis of ZPC and its impurity over the concentration range of 0.3-1.4 and 0.05-0.8 µg/band with accuracy of mean percentage recovery 99.92% ± 1.521 and 99.28% ± 2.296, respectively. The method is based on the separation of two components followed by densitometric measurement of the separated peaks at 305 nm. The separation was carried out on silica gel HPTLC F254 plates, using chloroform-methanol-glacial acetic acid (9:1:0.1, by volume) as a developing system. The suggested method was validated according to International Conference on Harmonization guidelines and can be applied for routine analysis in quality control laboratories. The results obtained by the proposed method were statistically compared with the reported method revealing high accuracy and good precision.