STABILITY INDICATING AND COST EFFECTIVE ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF VILOXAZINE BY USING REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY

Abstract

The current investigation was pointed at developing and progressively validating novel, simple, responsive and
stable RP-HPLC method for the measurement of active pharmaceutical ingredient of Viloxazine. A simple,
selective, validated and well-defined stability that shows isocraticRP-HPLC methodology for the quantitative
determination of Viloxazine. The chromatographic strategy utilized X-bridge phenyl column of dimensions 250x4.6
mm, 5 µ, using isocratic elution with a mobile phase of acetonitrile and 0.1% Tri fluoro acetic acid (60:40). A flow
rate of 1 ml/min and a detector wavelength of 221 nm utilizing the PDA detector were given in the instrumental
settings. Validation of the proposed method was carried out according to an international conference on
harmonization (ICH) guidelines The calibration chart plotted was linear with a regression coefficient of R2 > 0.999,
means the linearity was within the limit. Recovery, specificity, linearity, accuracy, robustness, ruggedness were
determined as a part of method validation and the results were found to be within the acceptable range. The
proposed method to be fast, simple, feasible and affordable in assay condition. During stability tests, it can be used
for routine analysis of the selected drug.