AN EMERGING PARADIGM EXOSOMES: COMPOSITION, A RAPID ECONOMICAL RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF FLUOXETINE IN API AND MARKETED FORMULATION

The objective of the current study is to develop a more sensitive, rapid, precise and economic analytically validated RP-HPLC method for the estimation of frequently prescribed anti-Depressant FLUOXETINE which is a selective serotonin reuptake inhibitor. The different analytical performance parameters such as linearity, precision, accuracy, range, LOD, LOQ were detected according to ICH guidelines. Chromatographic separation was carried out by quaternary system using Zorbax SB C-18 (150mm x 4.6mm id, mu 5m particle size) utilizing AGILENT 1260 Infinity Quaternary LC System equipped with G1314F VW detector using Zorbax C-18 column. The mobile phase consisted of Methanol: Acetonitrile: formic acid in Water (0.15 v/v) in the ratio 15: 55: 30 v/v at a flow rate of 1ml/min and temperature of 35 degrees C. Total run time was given 10 minutes using VWD detector at 227nm. The proposed method is accurate and precise with recoveries in the range of 98-102% and retention time was found to be 1.143 min. The linearity is observed in the concentration range of 5-50 mu g/ml, (r(2)=0.999). The reliability of the method was done by evaluation of precision (interday and intraday) %R.S.D was < 2%. The LOD and LOQ was found to be 0.130 mu g/ml and 0.872 mu g/ml respectively. The high percentage of recovery and low percentage of coefficient of variance confirm the suitability of method for estimation of Fluoxetine in pure and marketed form. It was successfully validated in accordance with ICH guidelines.