SPECTROPHOTOMETRIC METHODS FOR THE DETERMINATION OF TADALAFIL IN PHARMACEUTICAL FORMS
Keywords:
Tadalafil, Spectrophotometric determination, Oxidation, Drug formulationAbstract
Objective: To develop and validate simple and reproducible spectrophotometric methods for the determination of Tadalafil (TDF) in pure and pharmaceutical form.
Methods: Methods (A and B) were developed, method A is based on oxidation of (TDF) with a known excess amount of Ce(IV) then estimation of the unreacted amount of Methyl orange (MO) dye at 507 nm, Method B is based on the oxidation of (TDF) with excess N-bromosuccinamide then estimation the amount of Indigo carmine (IC) at 610 nm.
Results: The methods were linear in the concentration ranges 18–60 and 10–55 µg/ml with correlation coefficients of 0.993 and 0.992 and limits of detection LOD of 10.5 and 5.3 µg/ml for the two methods respectively. The proposed methods were applied for the determination of the drug in pharmaceutical formulations with recovery and relative standard deviations of 97% ± 1.4 and 98% ± 1.1 for the two methods.
Conclusion: the developed methods are equally accurate, precise and reproducible compared to the official methods.
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