DEVELOPMENT AND VALIDATION OF NEW ANALYTICAL METHOD FOR THE DETERMINATION OF PARTICLE SIZE DISTRIBUTION OF TADALAFIL DRUG SUBSTANCE USING LASER PARTICLE ANALYZER.

The Malvern Mastersizer 3000 laser particle size analyzer and HydroMV wet sampler were used, and the parameters are set as follows: sample refractive index 1.52, funnel width 2.0mm, dispersion air pressure 4.0 bar, ultrasonic intensity 50%, ultrasonic time 30s, stirring speed 1600rpm, laser obscuration 8% ~ 15%. The mean values of particle size distribution d (0.1), d (0.5), and d (0.9) of 3 batches of tadalafil drug substance were 0.819 µm, 2.79 µm, and 8.44 µm, respectively. The measured results were basically consistent with the microscopic method. The method is simple, accurate and precise, and suitable for the particle size determination of tadalafil drug substance. [ABSTRACT FROM AUTHOR]