e -Issn : 0976 - 3651
Print-Issn : 2229-7480

  ABSTRACT

METHOD DEVELOPMENT AND VALIDATION OF ATOMOXETINE HCl IN PURE AND PHARMACEUTICAL DOSAGE FORM BY RP-HPLC METHOD

A simple and reliable reverse phase high-performance liquid chromatography method was developed and validated for Atomoxetine HCl in pure and pharmaceutical dosage form. The method was developed on symmetric C18 (4.6 x 150mm, 5 m, Make: Agilent), with a mobile phase of phosphate buffer (PH 3.0): Methanol (30:70) %v/v. The effluent was monitored by Waters HPLC model containing Alliance 2695 with 2487 detector, variable wavelength prominence UV/ VIS detector SPD- 20A (VP series). Calibration curve was linear over the concentration range of 100 –140μg/ml. For inter–day and intra–day precision % relative standard deviation values were found to be 0.07% and 0.3% respectively. Recovery of Atomoxetine HCl was found to be in the range of 99.80 -101.40%. The limit of detection (LOD) and quantitation (LOQ) were 0.298 and 0.998μg/ml, respectively. The retention time and run time was very short; hence it is cost effective, making it more economical and rapid. Hence, this method can be used for the analysis of large number of samples.

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