SIMULTANEOUS DETERMINATION OF FLUPENTIXOL AND NORTRIPTYLINE HCl USING RP-HPLC WITH PDA DETECTOR
Keywords:Nortriptyline HCl, Flupentixol, RP-HPLC, Development, Validation
Objective: In the current investigation, to separated and validate the cancer healing drugs (Nortriptyline HCl and Flupentixol) through the HPLC (e-2695) instrument containing a PDA detector.
Methods: A simple, selective, validated and well-defined stability that shows isocratic RP-HPLC methodology for the quantitative determination of Nortriptyline HCl and Flupentixol. The chromatographic strategy utilized Agilent eclipse XDB column of dimensions 250x4.6 mm, 5 micron, using isocratic elution with a mobile phase of Methanol and 0.1% ortho phosphoric acid (40:60). A flow rate of 1 ml/min and a detector wavelength of 250 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.
Results: LOD and LOQ concentrations for Flupentixol were 0.015 µg/ml, 0.05 µg/ml and for Nortriptyline HCl were 0.3 µg/ml, 1.0 µg/ml. The calibration charts plotted were linear with a regression coefficient of R2 > 0.999. 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.
Conclusion: The proposed method to be fast, simple, feasible and affordable in assay condition. During stability tests, it can be used for routine analysis of production samples and to verify the quality of drug samples during stability studies.
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