Method Development and Validation of Zopiclone by RP-HPLC.

A simple, sensitive, rapid and selective isocratic reversed phase High Performance Liquid Chromatographic (HPLC) method has been developed for  Zopiclone from bulk drug using a mobile phase consisting mixture of Acetonitrile : Buffer (pH 2.8) (80:20v/v)  Composition of buffer: (0.272gm in 200ml HPLC water  and pH adjusted to 2.8 using  ortho Phosphoric acid)  at the flow rate of 1.0 mL/min. A Cosmosil C18 (250 cm x 4.6 mm, 5 μm) column was used as stationary phase. The retention time of Zopiclone found to be 2.19 min. The eluent were detected at 303 nm. Linearity was observed in the concentration range of 50-250 ppm for Zopiclone. Percent recoveries obtained for Zopiclone were 98.66%. The correlation coefficient for Zopiclone was found to be 0.998. After performing analysis by different analysts, it was found that the RP-HPLC method for the determination of Zopiclone was found to be Rugged. Percent RSD for robustness was well within the acceptable USP limits, ensuring that the proposed method was robust. The LOD were 0.22 µg/ml Zopiclone,. For Zopiclone, the LOQ were found to be 0.86 µg/ml. This demonstrated that the developed RP-HPLC method was simple, linear, precise, accurate, robust, and Rugged, could be conveniently adopted for the routine quality control analysis of Zopiclone.