Development and Validation of RP-HPLC-PDA Method for the Estimation of Fluoxetine Hydrochloride in Bulk, Mouth Dissolving Films and in Dissolution Samples Check Access

Selective serotonin reuptake inhibitor, fluoxetine hydrochloride (FLX) is a drug of choice for treating depression, obsessive-compulsive disorder (OCD), bulimia nervosa, etc. Even though FLX dosage forms such as tablets, capsules, oral solutions, and syrups are already available commercially, there is a considerable need for developing modified or immediate-release formulations with a quick onset of action and high bioavailability. The goal of this research is to provide a quick, practical, and cost-effective RP-HPLC-PDA approach for determining Fluoxetine hydrochloride (FLX) in bulk, mouth dissolving films (MDFs), and dissolution samples. A reverse-phase HPLC with chromatographic parameters like inertsil ODS3 column (150×4.6mm, 5µm), mobile phase composition of 10mM Ammonium acetate: Acetonitrile (58:42v/v), flow rate - 1.3mL/min, 20 μL injection volume in isocratic mode, wavelength at 226nm and a PDA detector is used to attain the peaks. Using the efficient liquid chromatographic conditions, FLX was eluted at retention time of 4.2min and a good linearity was seen over a concentration of 2-10µg/mL. The correlation coefficient (R2) was 0.999. The LOD and LOQ were 0.184μg/mL and 0.558μg/mL, respectively. The established technique was validated for method validation parameters like accuracy, precision, assay, linearity, specificity, robustness, LOD, and LOQ as per ICH Q2B recommendations. All the validation parameters were within acceptable limits. Hence, for the FLX estimation in bulk, MDFs and in-vitro dissolution samples the established technique can be utilized to produce reproducible results.