Development and validation of a reversed-phase HPLC method for the estimation of zolpidem in bulk drug and tablets

In the present study an isocratic reversed-phase high-performance liquid chromatography method was developed for the estimation of zolpidem in bulk drug and pharmaceutical dosage forms. the quantification was carried out on c 18 columns. a mixture of acetonitrile-ammonium acetate (ph = 8.0,0.02 m) (60: 40 v/v) was used as the mobile phase,at flow rate of 1.0 ml/min and the determination wavelength at 245 nm. the retention time of zolpidem was found to be 3-5 min. the validation of the proposed method was carried out for specificity,linearity,accuracy,precision,limit of detection,limit of quantification,and robustness. the linear dynamic range was from 2.5 to 30 μg ml -1. regression equation was found to be y = 0.1416 x + 0.0183 with correlation coefficient r = 0.9996. the percentage recovery obtained for zolpidem was greater than 96.5. limit of quantification and limit of detection were found to be 2.5 μg ml -1 and 0.83 μg ml -1,respectively. the developed method can be used for routine quality control analysis of zolpidem in tablet formulations. © 2013 e. konoz et al.