HPLC测定灯盏花素-Soluplus(R)固体分散体的体外溶出度
Determination of in vitro dissolution of Breviscapine-Soluplus? solid dispersion by HPLC
解仲伯 1周雨华 2林华庆 1刘荣3
作者信息
- 1. 广东药科大学广东省药物新剂型重点实验室,广东广州510006;广东高校药物缓控释制剂工程技术研究中心,广东广州510006
- 2. 广州玻思韬控释药业有限公司,广东广州510530
- 3. 广州玻思韬控释药业有限公司,广东广州510530;美国奥斯达药业,新泽西州爱迪生08837
- 折叠
摘要
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(ChP2015)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.
Abstract
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.
关键词
灯盏花素/固体分散体/高效液相色谱法/体外溶出度/Soluplus(R)Key words
Breviscapine/solid dispersion/high performance liquid chromatography (HPLC)/in vitro dissolution/Soluplus?引用本文复制引用
基金项目
广东省部产学研合作专项资金(2013B090200031)
广东省引进创新创业团队专项资金(2014ZT05Y018)
出版年
2017
NETL
NSTL
万方数据