Determination of in vitro dissolution of Breviscapine-Soluplus? solid dispersion by HPLC
Objective To establish a determination method of in vitro dissolution of Breviscapine solid dispersion, determine the dissolution and to provide a scientific basis for quality control.Methods The test was carried out by using the second method (Paddle Method) of Chinese Pharmacopoeia 2015 edition Volume Ⅳ General Role 0931.The dissolution of Breviscapine solid dispersion was determined by high performance liquid chromatography (HPLC).Results The accuracy and precision of HPLC for the determination of Breviscapine solid dispersion were good,which was not interference with the carrier of solid dispersion and dissolution medium;the linearity was good in the range of 2.2-52.8μg/mL of Breviscapine, the average recovery was 101.6% and RSD was 1.3%, the alterations of flow rate or the proportion of compositions of mobile phase and chromatographic column had no influence on dissolution determination.Conclusions The method established for dissolution was characterized by simplicity and celerity, specificity, good robustness, accuracy and reliability, and can be used for quality control of Breviscapine solid dispersion.
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