Abstract
DEVELOPMENT AND VALIDATION OF A STABILITY-INDICATING RP-HPLC METHOD FOR ANALYSIS OF TADALAFIL IN BULK AND TABLET FORMULATION

Kharat S.S.*, Andhale S.P. and Saudagar R.B.

ABSTRACT

The simple, selective, accurate, efficient and reproducible Reverse Phase-High Performance Liquid Chromatography (RP-HPLC) method was developed and validated for analysis of tadalafil in bulk and tablet dosage form. The separation was carried out on Hexon C18 (250mm x 4.6ID, Particle size: 5 micron) in isocratic mode column using the mobile phase composition was Methanol and Water (80:20% v/v) adjusted pH to 3.0 with orthophosphoric acid. The injection volume was 20μl and detection wavelength was used 220 nm. The flow rate was 0.8 ml/min and effluent was detected at 220 nm with a sharp peak was obtained for TDL at a retention time of 4.8 ± 0.01 min. Linearity was observed in the concentration range from 15 to 75 μg/ml for tadalafil with a correlation coefficient of (r2) 0.9994. The percentage recovery was within the range between 99.62 to 100.43% for tadalafil. The percentage relative standard deviation for accuracy and precision was found to be less than 2%. The method was validated according to International Conference on Harmonisation guidelines in terms of linearity, accuracy, precision and specificity. Hence, the proposed method can be utilized for routine quality control of tadalafil in bulk and tablet dosage form.

Keywords: International conference on harmonisation guidelines, tadalafil (TDL), ultraviolet detection, validation, reverse phase high performance liquid chromatography.


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