Study on the dissolution curves of Paliperidone Sustained-release Tablets
ZHANG Jixin
CHANG Gang
HUANG Cuiping
ZHANG Qin
ZHANG Na
WEI Da
Abstract：Objective To establish a method for determination of the dissolution curves of Paliperidone Sustained-release Tablets.Methods The dissolution curve was investigated by paddle method.With the dissolution media of three different pH solutions and adding a sedimentation basket,the rotation speed was set at 50 r·min-1.Detection was carried out by HPLC.A C18 chromatographic column was used,with 30 mmol·L-1 tetrabutylammonium hydrogen sulfate solution-methanol(80∶20)as the mobile phase.The flow rate was 1.0 mL·min-1,the column temperature was 40 ℃,and the detection wavelength was 275 nm.Results The linear relationship of paliperidone in all mediums was good,and the average recoveries ranged from 98.0％to 102.0％.The RSD of accuracy,precision and stability tests were all less than 2％.The dissolution curve of the self-developed agent and the original agent was determined,and the cumulative dissolution amount of the sample was not less than 85％in 24 hours.Conclusion The method has good specificity and a good linear relationship within dissolution range.The precision and accuracy meet the requirements.It can be used for quality control and dissolution curve comparison in the development of Paliperidone Sustained-release Tablets.
Keywords：PaliperidoneHPLCDissolution profileValidation
Publication Date：2026-01-30
Online Publishing Date：2026-03-24(First online date of this platform, not the publication date of the document)
Pages：4( 36-39 )