盐酸多柔比星埋植缓释片含量测定及其释放度的考察

Assay of Doxorubicin Hydrochloride Delayed-Release Implant Tablets

以生物降解聚乳酸为载体 ,制备了盐酸多柔比星埋植缓释片。采用高效液相色谱法测定缓释片中盐酸多柔比星的含量及释放度。结果表明 :采用 Chrom analysis C1 8柱 ,水 -乙腈 (6 8∶ 32 ) (p H 2 .4)为流动相 ,检测波长 2 5 4nm。在 4～ 2 0 μg/ml浓度范围内线性关系良好 ,回收率满意。此外 ,释放度测定结果表明该缓释片可使盐酸多柔比星释放期延长至 10 d左右。

A HPLC method was developed to assay doxorubicin hydrochloride delayed-release implant tablets and their release rate, using Chromanalysis C 18 column, water-acetonitrile (68∶32) (adjusted to pH 2.4 with 85% phosphoric acid) as mobile phase, and 254 nm wavelength detector. The standard curve had a good linearity in the concentration range of 4~20 μg/ml. The average recovery was satisfactory. The results showed that the tablets prepared with polylactic acid could keep prolonged drug release until about ten days.