摘要
目的:建立阿达帕林脂质体中药物含量和包封率的 HPLC 测定方法。方法:采用 Hypersil ODS 2柱(250 mm×4.6 mm,5μm),以20 mmol·L^(-1)醋酸铵溶液(用氨水调 pH 至7.4)-甲醇(10:90)为流动相,流速1.0 mL·min^(-1),柱温30℃,检测波长270 nm。采用4℃、10000 r·min^(-1)离心30 min 分离脂质体和游离药物,测定包封率。结果:在本色谱条件下辅料和溶剂不干扰药物测定,阿达帕林进样浓度在6.12～36.72μg·mL^(-1)范围内与峰面积呈现良好线性关系(r=0.9996),回收率在98.64%～103.0%之间(RSD 为0.59%～0.90%),日内及日间精密度的 RSD 均小于1%(n=5)。高速离心分离法对游离药物的回收率为95.55%～100.3%(RSD 为1.3%～1.4%)。结论:采用高速离心-HPLC 法测定阿达帕林脂质体中药物含量和包封率简便快速,结果可靠。
Objective：To establish an HPLC method for the determination of content and entrapment efficiency of adapalene liposomes. Method ：A Hypersil ODS 2 column（250 mm × 4. 6 mm,5 μm）was used with 20 mmol · L^-1 ammonium acetate solution（adjusted to pH 7.4 with ammonia solution） -methanol（ 10： 90）as the mobile phase at a flow rate of 1.0 mL · min^ -1. The UV detection was set at 270 nm. The column temperature was 30 ℃. Entrapment efficiency was determined after the separation of the unentrapped drug by centrifugation at 10000 r · min^-1 for 30 min at 4 ℃. Results：h was found that the excipients in the liposome did not interfere with the assay. A good linear relationship was found between peak area and the concentration of adapalene in the range of 6. 12 - 36. 72 μg · mL^-1 （r =0. 9996） ,the sample recoveries were 98. 64% -103.0%with RSD of 0. 59% -0. 90% ,RSDs of the intra - and inter - day precision were lower than 1% （ n = 5 ）. The recovery of free adapal with RSD of 1.3% - 1.4% from liposome suspensions by high - speed centrifugation. quick, accurate, feasible and applicable.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2007年第9期1462-1465,共4页
Chinese Journal of Pharmaceutical Analysis
关键词
阿达帕林脂质体
高效液相色谱法
含量测定
包封率
adapalene liposomes
HPLC
content
entrapment efficiency ene was 95.55% - 100. 3% Conclusion： The method is
