Abstract

METHOD DEVELOPMENT AND VALIDATION OF FLUPHENAZINE HCl TABLET BY RP-HPLC

Nutan Rao* and Shraddha Gaur

ABSTRACT

A simple, fast, accurate, sensitive, specific and accurate instrumental planar chromatographic method has been developed and validated for the quantification of Fluphenazine HCl tabletFor system development and validation the RP-HPLC Shimadzu LC Prominence-i 2030 model consisting of UV detector and auto sampler was used. Wavelength used for detection of Fluphenazine HCl was 254 nm. The calibration plots were linear with a correlation coefficient of 0.995. Intraday and interday precision, expressed as relative standard deviation (RSD), were found to be 0.25 and 0.21 respectively. Recovery of Fluphenazine HCl was between 99.5 and 100.5%, with RSD not more then 2. When the approach was used to measure Fluphenazine HCl in actual pharmaceutical samples, product content was within the approved Limits (95–110 percent of the labeled content of formulations). Because the method is sensitive, precise, accurate, and selective for the compound tested, it can be used for routine quality control testing of Fluphenazine HCl in solid dosage form.

Keywords: Fluphenazine HCl, HPLC, Validation, Method Development.