Development and validation of Quetiapine fumarate in pure and pharmaceutical formulation by UV-Spectrophotometric method

A simple, sensitive, selective, economical and reproducible UV spectrophotometric method has been developed for the quantitative determination of QTF in bulk drug and in pharmaceutical dosage forms. The methods are based on measurement of absorbance of QTF solution in ethanol at 207 nm. Beer’s law is obeyed over the linear range 1-5 μg/mL of QTF for the method with apparent molar absorptivity value of 1434.41281 L mol-1cm-1. Limits of quantification (LOQ) and detection (LOD) are also reported. The methods were validated in accordance with the current ICH guidelines. The precision results, expressed by intra-day and inter-day relative standard deviation values, are satisfactory i.e % RSD 100.22% and 99.83 % respectively. The accuracy is also satisfactory (%RSD 0.39) and percentage recoveries are in the range 99.34- 100.11% with the standard deviation of 0.39. Method have excellent linearity and range (r2 =/0.998).

Author(s): V G Prasanth , Susamma Cicy Eapen , Sheeja Velayudhan Kutty and Jyothi T S

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