Stability‐Indicating RP‐HPLC Method Development and Validation for the Quantification of Fluphenazine Tablets in Solid Oral Dosage Form

The present manuscript discusses the development of simple, rapid, specific, precision, accuracy stability indicating HPLC method for the analysis of fluphenazine tablets dosage form. The chromatographic separation was achieved using 0.02-M phosphate buffer (pH 3.0) and adjusted with orthophosphoric acid solution as a buffer. We mixed buffer, methanol, and acetonitrile in the ratio of 500:300:200 (v/v/v) as the mobile phase. The detection of component was made at 254 nm for fluphenazine hydrochloride. We evaluated stress studies under different types of ICH conditions. The optimized HPLC method was validated as per the current ICH guidelines. The validated HPLC method was obtained highly specific with linearity ranging between 2.5 and 120 μg/mL of fluphenazine HCl and the correlation coefficient for the drug > 0.999. The method showed more than 97% accuracy. In stress studies, the fluphenazine HCl was found to be sensitive in photolytic stress conditions and oxidation stress condition. It is a typical antipsychotic drug and used for the treatment of schizophrenia and bipolar disorder. The method was found to be suitable for the quality control of fluphenazine hydrochloride in the tablet as well as in stability-indicating studies. The method was applied to analyze stability samples.