Abstract
DEVELOPMENT & VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR QUANTITATIVE ESTIMATION OF QUETIAPINE FUMARATE AND ITS IMPURITIES IN DRUG SUBSTANCE AS PER ICH GUIDELINES

T. Benjamin* and Dr. D. Ramachandran

ABSTRACT

The analysis of improved RP-HPLC method for the separation and quantification of Quetiapine fumarate and its impurities are described. Samples are analysed by means of reverse phase (RP-HPLC) using an Zodiac C18, 100 x 4.6 mm, 3μm, and the mobile phase consists of two Channels A and B. Channel-A pH 6.50 buffer: methanol (500:500%v/v) and Channel-B: pH 6.50 buffer: methanol (150:850%v/v),. The flow rate is 1.0 ml/min. The column temperature was maintained at 45°C and sample temperature was maintained at ambient (25°C) and wavelength fixed at 252nm UV-detection. It is found that the method of RP-HPLC with UV-detection system for the analysis of Quetiapine fumarate impurities are straight forward and applied in qualitative and quantitative analysis. The developed LC method was validated with respect to specificity, precision, linearity, ruggedness and robustness. Validation study compared as per ICH guideline.

Keywords: Quetiapine fumarate, estimation of related substances, liquid chromatography.


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