Determination of Particle Size Distribution of Lurasidone Hydrochloride Bulk Drug by Laser Scattering Method
A method for determining the particle size distribution of lurasidone hydrochloride(1)bulk drug was established and validated.A laser particle size analyzer was used with organic injection mode.By examining the parameters such as dispersant and dosage,refractive index and absorption rate of the sample material,ultrasound time,and stirring cycle speed,the accuracy,precision,stability,and durability of the method were verified.The results showed that the parameters of the established method for determination of particle size distrubition of 1 were as follows:the refractive index of the sample material was 1.65,the absorption index was 0.01,the refractive index of the dispersant was 1.42,the light shielding degree was 12％-20％,and the stirring cycle speed was 2 500 r/min,the sample measurement time and background time were both 10 s,and the sample was measured for 6 times.This method has high precision,good stability and durability.The RSDs of d(0.5),d(0.1),and d(0.9)of 1 were all less than 3％,which met the specified requirements and could be used for particle size determination of 1 bulk drug.
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