A validated method without derivatization for the determination of Letrozole by high performance liquid chromatography-fluorimetric method for pharmaceutical preparation

Year 2018, Volume: 48 Issue: 2, 38 - 42, 31.08.2018

Cem Kaplan , Durisehvar Ozer Unal

Abstract

DOI: 10.5152.IstanbulJPharm.2018.397094

A high performance liquid chromatography
method has been developed for determination of letrozole in tablets. The method
has developed in reverse phase column with acetonitrile-50.0 mM phosphoric acid
solution, pH:7 (50:50, v/v) and 0.7 mL/min flow rate by using a fluorimetric
detector. Letrozole has natural fluorescence properties, and there is no need
for derivatization for this molecule. The detector was set at 256, 585 nm for
excitation and emission wavelength respectively. The method was validated in
accuracy, precision, specificity, linearity and system suitability parameters
are studied.  The linear range was found
50-700 ng/mL. The limit of detection and quantification for letrozole was found
to be 14-50 ng/mL respectively. The recovery of drug is found to be 98.8%. The
developed method has been validated and successfully applied to tablet analysis
of drug substance. This method is simple, reproducible and can be used safely
for routine analysis of letrozole in tablets.

Keywords

Letrozole, HPLC-FLD, pharmaceutical preparation

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