Forced degradation studies, quantification and in-vitro dissolution studies of tadalafil by spectrofluorimetry
Abstract
Objective: In the present study a simple and sensitive spectrofluorimetric method has been developed and validated for the estimation of tadalafil in pure and pharmaceutical dosage forms including its in-vitro dissolution studies and forced degradation studies. Methods: Fluorescence intensity of tadalafil measured at an emission wavelength (λem) of 676 nm after excitation at 292 nm in dimethyl sulphoxide as solvent by using spectrofluorimeter RF-5301 PC instrument.Results: Linearity was obeyed in the range of 0.1-2.0 µg/mL with good correlation coefficient of 0.9995. The limit of detection (LOD) and limit of quantification (LOQ) for this method are 0.074 and 0.22 µg/mL respectively. The developed method was statistically validated as per ICH guidelines. The percentage relative standard deviation values were found to be less than 2 for accuracy and precision studies. The results obtained were in good agreement with the labeled amounts of the marketed formulations.Conclusion: The proposed method is simple, sensitive and specific. Hence it can be applied for quantification of tadalafil in pharmaceutical dosage forms.
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