Abstract

Development and validation of new RP-HPLCmethod with UVdetection for determination of novel anti-psychotic agent quetiapine in human plasma

Author(s): Vikas Sharma, Ashok K.Tiwary, Subheet Jain

A high performance liquid chromatographic method has been developed and validated for estimation of quetiapine, an atypical anti-psychotic agent, in human plasma. Method was developed on the knowledge of previously reported literature and according to the need of improvement required on basis of instrument and experimentation technique(s) available. Separation was achieved by usingC18 reversed phase column (Nova-Pack, 5 m, 4.6mm 250mm) and amobile phase comprising of acetonotrile- disodiumhydrogen orthophosphate solution (35:65). The UV detector was set at 220 nm and carbamazepine was used as internal standard. Acareful pre-treatment procedure of plasma sampleswas developed using liquid liquid extraction (LLE) involving ethyl acetate-hexanemixture. The limit of quantification was 100 ng/ml and linearitywas observed for calibration curves between 103.44 ng/ ml to 1403.05 ng/ml. The relative standard deviation (RSD or%CV) for all validation studies was within +15%. The method proves to be simple, sensitive enough for plasma estimation of quetiapine. The method developed was validated in terms of accuracy, precision, ruggedness, stability and dilution integrity.