Abstract
ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF FLUPENTIXOL AND MELITRACEN IN COMBINED PHARMACEUTICAL DOSAGE FORM BY RP-HPLC

Tadikonda Rama Rao* and Alwala Ramya

ABSTRACT

A simple, specific, precise, and efficient method for the Simultaneous estimation of Flupentixol and Melitracen in pure and pharmaceutical dosage forms by a Reverse Phase-High Performance Liquid Chromatography method is developed and validated. Selected mobile phase was in a combination of Acetonitrile and Acetate buffer (pH-4.3) (35:65% v/v). Optimized column is a Develosil C18 (4.6mm×250mm) 5 μm particle size and at a flow rate of 1.0 mL/min with detection wavelength at 238 nm for Flupentixol and Melitracen. In our study, the validation of analytical method for determination of Flupentixol and Melitracen in pure and pharmaceutical dosage forms was performed in accordance the parameters including system suitability, specificity, linearity of response, accuracy, precision (reproducibility & repeatability), robustness (change of wave length±2 nm). The method is validated according to ICH guidelines. In RP-HPLC method, the calibration graphs were linear in the concentration range of 10-30 μg/ml for Flupentixol and 30-90 μg/ml for Melitracen with percentage recoveries within the limits. The results obtained by RP-HPLC methods are rapid, accurate and precise. Therefore proposed method can be used for routine analysis of Flupentixol and Melitracen in the pure form as well as in combined pharmaceutical dosage form.

Keywords: Flupentixol, Melitracen, RP-HPLC, Method Development, Validation.


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