Abstract

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF FLUOXETINE HYDROCHLORIDE AND QUETIAPINE FUMARATE

Ramesh L. Sawant, Sonali T. Gade*, Shubhangi B. Perane and Santosh B. Kharat

Abstract

Objectives: The objective of the existing study was to develop a simple, precise, accurate, rapid, and economical UV Spectrophotometric and isocratic reversed-phase high performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of fluoxetine HCl and quetiapine fumarate in synthetic mixture. Methods: In UV Spectrophotometric method 0.1N HCl is used as solvent. Method I is based on simultaneous equation method, known as Vierodt’s method. Method II is based on principle of Qanalysis, known as absorbance ratio method. Isocratic RP-HPLC separation was achieved on an Hibar R 250 × 4.6 mm HPLC column Purosphens R STAR RP-18, using a mobile phase of phosphate buffer (KH2PO4 and K2HPO4):acetonitrile (55:45v/v) at a flow rate of 1.0ml/min. The method was used successfully for the simultaneous determination of fluoxetine HCl and quetiapine fumarate in synthetic mixture. Result: In method I Fluoxetine HCl and quetiapine fumarate show absorbance maxima at 228 nm and 254 nm. In method II both drugs was measured at 233 nm (Isobestic point) and 254 nm (λmax of Quetiapine fumarate). In this method absorbance of Fluoxetine HCl and Quetiapine fumarate obeys Beer’s law in the concentration range of 5 to 30μg/ml. The RP-HPLC method results in excellent separation with good resolution between the two analyte. The retention times of fluoxetine HCl and quetiapine fumarate was found to be 6.667 and 4.458 mins. Conclusion: The developed methods are precise, accurate, rapid, simple, reproducible and economical for simultaneous estimation of fluoxetine HCl and quetiapine fumarate in synthetic mixture.

Keywords: Fluoxetine HCl, Quetiapine fumarate, Simultaneous estimation method, Absorbance ratio method, Validation, RP-HPLC.