Determination of the particle size distribution of Tobramycin dexamethasone eye drops and its active pharmaceutical ingredient Dexamethasone by Laser scattering method
OBJECTIVE To determine the particle size Distribution of Tobramycin dexamethasone eye drops and dexamethasone by Laser scattering method.METHODS The Malvern Mastersizer 3000 laser particle size analyzer with Hydro EV wet sampler was used.The dispersion medium was Dexamethasone saturated solution with refractive index of 1.33,sample refractive index was 1.59,sample absorbency was 0.001,measuring time for background and sample was 10 s,laser obscuration was 5％-10％,and stirring rate was 2 × 103 r·min-1.The preparation was directly determined after 2 min of equilibration,the Dexamethasone active pharmaceutical ingredient(API)was prepared with 0.01％Tween 20,and was determined after 20％ultrasonicaction 5 min and 2％ultrasonicaction 5 min.RESULTS The relative standard deviation values(RSD)of d(0.1),d(0.5)and d(0.9)of the particle size distribution of the preparation and Dexamethasone were all less than 5％.The results were generally consistent with the microscopy method.CONCLUSION The method is sample,accurate and reproducible,which is suitable for the particle size control of Tobramycin dexamethasone eye drops and Dexamethasone API.
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