Abstract

A NEW RP-HPLC METHOD DEVELOPMENT & VALIDATION FOR ESTIMATION OF QUETIAPINE FUMARATE IN HUMAN PLASMA

Abstract

A new reverse phase high performance liquid chromatography (RP-HPLC) method for the quantitative determination of Quetiapine Fumarate in human plasma was developed and validated as per US-FDA guidelines. The drug was spiked in the plasma and extracted with mobile phase by Precipitation method. The extracted analyte was injected into Symmetry C18 (4.6 x 150mm, 5 m, Make: Thermo) or equivalent, maintained at ambient temperature and effluent was monitored at 290 nm. The mobile phase consisting of Sodium Dihydrogen Phosphate: Methanol (35:65 v/v). The pH of the mobile phase was adjusted to 4.0 by using O-Phosphoric Acid. The flow rate was maintained at 1.0 mL/min. The developed method shows high specificity for Quetiapine. The calibration curve for Quetiapine was linear from 5 to30 μg/ml. The inter-day and intraday precision was found to be within limits. The proposed method has adequate sensitivity, reproducibility, and specificity for the determination of Quetiapine in Human Plasma. The Lower limit of quantification (LLOQ) for Quetiapine was found to be 0.05μg/ml. The Average % recovery was of the drug was found to be 99.74-100.32% (r2= 0.999) and reproducibility was found to be satisfactory. The proposed method is simple, fast, accurate, and precise for the quantification of Quetiapine Fumarate in the human plasma as well as for routine analysis in quality control. The method was validated for parameters like Selectivity, Sensitivity, Precision, Intermediate Precision, Accuracy, Linearity, Recovery & Stability. This RP -HPLC method is suitable for determining the concentration of Quetiapine in human plasma and it can applied for routine analysis for determination of the Quetiapine from dosage form during pharmacokinetic study.

Keywords: Quetiapine Fumarate, RP-HPLC, ICH, Validation, Human Plasma, US-FDA guideline.