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  • Development And Validation Of HPLC Method For Estimation Of Fluoxetine HCL In Bulk And Pharmaceutical Dosage Form
  • Photo Sanket Hire* Photo Smita Aher Photo Rushikesh Bachhav

  • 1Department of Pharmaceutical Quality Assurance, R.G. Sapkal College of Pharmacy, Anjanery, Nashik
    2Department of Pharmaceutical Chemistry, R.G. Sapkal College of Pharmacy, Anjanery, Nashik
    3Department of Pharmacology, R.G. Sapkal College of Pharmacy, Anjanery, Nashik

Abstract

A simple, sensitive and accurate RP-HPLC method has been developed for the determination of Fluoxetine HCL in bulk and marketed formulation. The method was developed after the several trials at the composition of Methanol: water (70:30), flow rate 1.0 ml/min and 264 nm wavelength of detection and retention time is 4.8 min. The method shows high sensitivity with linearity 5-25 µg/ml (regression equation: y = 203134x + 9713.5; r2 = 0.9997). The various parameters according to ICH guidelines and USP are followed for validating and testing of this method. The Detection limit and quantitation limit were found to be 0.008 µg ml–1 and 0.02 µg ml–1 respectively. The results demonstrated that the procedure is accurate, specific and reproducible (RSD <2%), and also being simple, cheap and less time consuming and appropriate for the determination of Fluoxetine HCL in bulk and Table dosage form.

Keywords

Fluoxetine HCL, HPLC method, Method development, Validation

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Photo
Sanket Hire
Corresponding author

Department of Pharmaceutical Quality Assurance, R.G. Sapkal College of Pharmacy, Anjanery, Nashik

Photo
Smita Aher
Co-author

Department of Pharmaceutical Chemistry, R.G. Sapkal College of Pharmacy, Anjanery, Nashik

Photo
Rushikesh Bachhav
Co-author

Department of Pharmacology, R.G. Sapkal College of Pharmacy, Anjanery, Nashik

Sanket Hire*, Smita Aher, Rushikesh Bachhav, Development And Validation Of HPLC Method For Estimation Of Fluoxetine HCL In Bulk And Pharmaceutical Dosage Form, Int. J. in Pharm. Sci., 2023, Vol 1, Issue 11, 81-90. https://doi.org/10.5281/zenodo.10065688

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