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.
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