Rapid Estimation of Tadalafil by Reverse-phase High-performance Liquid Chromatography Method in Bulk and Tablet...

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis

Background:

• Tadalafil is a widely used medication for erectile dysfunction and pulmonary arterial hypertension.
• Accurate and reliable analytical methods are crucial for quality control of pharmaceutical products.

Purpose of the Study:

• To develop and validate a simple, selective, precise, and accurate reverse-phase high-performance liquid chromatography (RP-HPLC) method for tadalafil analysis.
• To establish a method suitable for routine quality control of tadalafil in both bulk drug substance and finished tablet dosage forms.

Main Methods:

• Development of a RP-HPLC method using an Inertsil C18 column.
• Optimization of the mobile phase composition (phosphate buffer and acetonitrile) and flow rate.
• Validation of the method according to International Conference on Harmonisation (ICH) guidelines, assessing linearity, accuracy, precision, and specificity.

Main Results:

• The developed RP-HPLC method achieved a retention time of 4.01 min for tadalafil.
• Linearity was demonstrated in the concentration range of 60–140 μg/ml with a high correlation coefficient (r² = 0.9998).
• The method proved to be selective, precise, and accurate, meeting ICH validation criteria.

Conclusions:

• The proposed RP-HPLC method is simple, selective, precise, and accurate for tadalafil determination.
• This validated analytical technique is suitable for routine quality control of tadalafil in bulk and tablet formulations.
• The method provides a reliable tool for ensuring the quality and consistency of tadalafil drug products.