METHOD DEVELOPMENT AND VALIDATION OF QUETIAPINE FUMARATE BY RP - HPLC METHOD
About Author:
Sharath Kumar Pallikonda*1, Srikanth Subburu2, Shanker Reddy Soma2, Chandra Shekar Reddy3
1,2Vathsalya College Of Pharmacy,
Bhongir, Dist: Andhra Pradesh, India - 508 116
Abstract
A simple, sensitive, rapid, robust and reproducible method for the determination of Quetiapine fumarate in bulk and pharmaceutical formulation (Tablets) was developed using reverse phase high performance liquid chromatographic method (RP-HPLC). The RP-HPLC analysis was performed isocratically on XTERRA C18 (4.6X150mm), analytical column using a mobile phase consisting of ortho phosphorus buffer and acetonitirle in the Ratio of 60:40v/v, with a flow rate of 0.6ml/min. The analyte was monitored with UV detector at 290nm. The developed method Quetiapine fumarate elutes at a run time of 10 min. The proposed method is having linearity in the concentration range from 40 to 80 μg/mL of Quetiapine fumarate. The present method was validated with respect to system suitability, linearity, precision, limit of detection (LOD) and limit of quantification (LOQ), accuracy (recovery), ruggedness, and robustness. The proposed method can be readily utilized for bulk drug and pharmaceutical formulations.