HPLC测定灯盏花素-Soluplus~固体分散体的体外溶出度

Determination of in vitro dissolution of Breviscapine-Soluplus solid dispersion by HPLC

目的 建立高效液相色谱法（HPLC）测定灯盏花素-Soluplus固体分散体体外溶出度的方法,测定其体外溶出度,为灯盏花素-Soluplus固体分散体的质量控制提供科学依据。方法 照《中华人民共和国药典》2015版（Ch P2015）四部通则0931第二法（桨法）进行试验,采用高效液相色谱法测定灯盏花素-Soluplus固体分散体的体外溶出度。结果 HPLC对灯盏花素的测定准确度和精密度良好,固体分散体载体材料和溶出介质不干扰药物的检测;灯盏花素在2.2～52.8μg/mL范围内线性关系良好（r=0.9999）;平均回收率为101.6%,RSD为1.3%;流动相的流速、组成比例以及色谱柱的微小变动对溶出度测定均无影响。结论 本方法简单快捷,专属性强,耐用性好,准确可行,可用于灯盏花素-Soluplus固体分散体体外溶出度测定,也可用于质量控制。

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.