Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR ESTIMATION OF OLANZAPINE IN TABLET DOSAGE FORMS

R. Vijayageetha, K. Sahini, Chandanam Sreedhar and Bharani P.*

ABSTRACT

A simple, precise, rapid, economical and accurate Reversed phasehigh-performance liquid chromatographic (RP-HPLC) in gradientmode has been progressed for the estimation of Olanzapine in pureform and in its tablet dosage form. An Agilent water’s Bridge C18,(250mm×4.6mm, 5μm) column, with mobile phase consisting ofAcetonitrile and Ammonium acetate buffer pH 5.8 in the ratio of45:55v/v was used. The flow rate was adjusted to 1.0ml/min and thecolumn effluent was monitored at a wave length of 226nm. Theretention time was 4.18min. The detector response was linear forOlanzapine in the concentration range of 2-12μg/ml. The limit ofdetection (LOD) was found to be 0.69μg/ml. The limit ofquantification (LOQ) was 2.39μg/ml. The method was validated bydetermining its accuracy, precision and system suitability parameters.The results of the study explained that the proposed RP-HPLC method is simple, rapid,precise, economical and accurate, which can be used for the routine determination ofOlanzapine in pure drug and in its tablet dosage form.

Keywords: Olanzapine, RP-HPLC, Retention time, Validation.