To develop and validate high performance liquid chromatographic method for estimation of quetiapine fumarate from bulk and tablet dosage form. The separation was achieved on a C18 column using a mixture of phosphate buffer, acetonitrile and methanol in the ratio 50:40:10 v/v/v with a flow rate of 1 ml/min and detection wavelength at 245 nm. The method was validated for linearity, accuracy, precision and specificity as per ICH guidelines. The developed and validated method was successfully used for the quantitative analysis of commercially available dosage form. The retention time of quetiapine fumarate was found to be at 5.08 min. Linearity of the method was found to be in the concentration range of 10-80 μg/ml with correlation coefficient of 0.999. Limit of detection and limit of quantification for quetiapine were found to be 18.815 and 57.016 μg/ml respectively. The high percentage of recovery and low percentage of relative standard deviation confirm the suitability of the method for the estimation of quetiapine in bulk and tablet dosage form .
Pramod L. Ingale et al; A new, simple, specific, sensitive, rapid, accurate and precise RP-HPLC method was developed for the estimation of quetiapine fumarate in bulk and pharmaceutical formulations. Quetiapine fumarate was chromatographed on Microsorb-MV 100-5 C-18 (250 × 4.6 mm, 5 μm) column using UV detector. The mobile phase consisting acetonitrile and phosphate buffer (pH 3.0) in the ratio of 50:50 (v/v) at a flow rate of 1.0 ml/min with detection at 292 nm. The method was validated according to the ICH guidelines with respect to specificity, linearity, accuracy, precision and robustness