Determination of particle size of quetiapine fumarate oral suspension by laser diffraction method

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Affiliation: 1. Department of Pharmacy, Jiangsu Province Hospital of Chinese Medicine, Nanjing 210029, China 2. Jiangsu Sijiqing Biotechnology Co., Ltd, Nanjing 210061, China

Keywords: Quetiapine fumarate oral suspension Particle size Particle size distribution Laser diffraction method (wet method) Quality control

DOI: 10.12173/j.issn.2097-4922.202411079

Reference: ZHANG Yan, LIU Liucheng. Determination of particle size of quetiapine fumarate oral suspension by laser diffraction method[J]. Yaoxue QianYan Zazhi, 2025, 29(4): 575-581. DOI: 10.12173/j.issn.2097-4922.202411079.[Article in Chinese]  Copied

Abstract
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Abstract

Objective To establish a laser diffraction method for determining the particle size and particle size distribution of quetiapine fumarate oral suspension.

Methods The Hydro MV wet autosampler was used to conduct the particle size analysis of quetiapine fumarate oral suspension by laser diffraction method (wet method) and the methodological research. The dispersion solution concentration, agitation rate and obscuration were investigated, and precision and stability tests were conducted on the final particle size determination method.

Results The optimum parameters are as follows: dispersion was standard dispersion solution concentration, the agitation rate was 3 000 r/min and obscuration was 10%-15%. The RSD of D₁₀, D₅₀ and D₉₀ (the particle size values corresponding to cumulative distribution percentages of 10%, 50% and 90%, respectively) met the requirements in the precision and stability tests. The dissolution behavior of quetiapine fumarate oral suspension was consistent with the dissolution behavior of its active pharmaceutical ingredient.

Conclusion The laser diffraction method (wet method) is suitable for the measurement of quetiapine fumarate oral suspension particle size, and can be applied to the actual research and development as well as the quality control of the quetiapine fumarate oral suspension..

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References

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