A new simple, rapid, selective, precise and accurate isocratic reverse phase high performance liquid chromatography assay
has been developed and validated for the estimation of DOXEPIN in tablet formulation. The separation was achieved byusing C-18 column (250x4.6mm, 5μm in particle size) at ambient temperature coupled with a guard column of silica inmobile phase, Acetonitrile: Methanol (80:20) with the pH value adjusted to 6.85 .The flow rate of was 1.5ml/min and thedrug was detected using UV detector at the wavelength of 220nm and the run time was 6min. The retention time waswithin 3.56minutes. The percentage of RSD for precision and accuracy of the method was found to be less than 2%. Themethod was validated as per ICH guidelines. The proposed method was found to be accurate, repeatability and consistent.It was successfully applied for the analysis of the drug in marketed formulation and could be effectively used for theroutine analysis of formulation containing the drug without any alteration in the chromatography conditions.
Abstract