Abstract
Two simple spectrophotometric methods have been developed for the estimation of tadalafil in both pure and tablet dosage form. Methods A and B are based on the formation of ion‐pair complexes of the drug with dyes such as bromothymol blue (BTB) and bromocresol green (BCG) in acidic buffer solution followed by their extraction with chloroform to form yellow colored chromogen with absorption maxima at 420 nm and 415 nm respectively. Beer’s law is valid in the concentration range of 10‐50 mcg/mL for both the methods. These developed methods were validated for precision, accuracy, ruggedness and robustness. Statistical analysis proves that the methods are reproducible and selective for the routine analysis of the said drug.
Highlights
Tadalafil is a phosphodiesterase type 5- inhibitor, used in the management of erectile dysfunction
The tablet powder equivalent to 25 mg of tadalafil was transferred into 25 mL volumetric flask containing 15 mL of methanol and flask was kept for ultrasonication for 5 min, it was diluted up to the mark with methanol and the solution was filtered through Whatman filter paper No 41
In method A, aliquots of tadalafil ranging from 1-5 mL of standard solution were transferred into a series of separating funnel
Summary
Tadalafil is a phosphodiesterase type 5- inhibitor, used in the management of erectile dysfunction. Extensive literature survey revealed that the determination of the drug in pure and dosage forms are not official in any pharmacopoeia and require much more investigation. Standard solution of tadalafil was prepared by dissolving 50 mg in 50 mL and diluting 10 mL of this solution to 100 mL with methanol (100 mcg/mL).
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