CAJ | 학술논문

目的优化和确定反相高压液相色谱法测定紫杉醇固体分散体中紫杉醇的含量.方法色谱柱为Phenomenex ODS 3,流动相为甲醇-乙腈-水(40:30:30),流速为1 mL·min-1,柱温为40℃,检测波长为227 nm,内标物为炔诺酮.结果在4～40 μg·mL-1浓度范围内,紫杉醇浓度与紫杉醇/炔诺酮峰面积比之间具有良好的线性关系,r=0.9999.加样同收率为98.42%,RSD为1.19%.结论方法准确、可靠,不但可以用于测定紫杉醇在固体分散体中的含量,也可用于紫杉醇固体分散体溶出度的检查.
목적 우화화학정반상고압액상색보법측정자삼순고체분산체중자삼순적함량.방법 색보주위Phenomenex ODS 3,류동상위갑순-을정-수(40:30:30),류속위1 mL·min-1,주온위40℃,검측파장위227 nm,내표물위결낙동.결과 재4～40 μg·mL-1농도범위내,자삼순농도여자삼순/결낙동봉면적비지간구유량호적선성관계,r=0.9999.가양동수솔위98.42%,RSD위1.19%.결론 방법준학、가고,불단가이용우측정자삼순재고체분산체중적함량,야가용우자삼순고체분산체용출도적검사.
Aim To develop and validate a RP-HPLC method for the analysis of paclitaxel in a solid dispersion. Methods Paclitaxel and the internal standard norethisterone were separated using a Phenomenex ODS 3 column and monitored at a wavelength at 227 nm. The isocratic mobile phase consisting of methanol-acetonitrile-water (40:30:30, V/V) was pumped at a flow-rate of 1.0 mL·min-1. The dissolution studies were performed according to published studies. Results Under these chromatographic conditions, the calibration curve was linear in the range of 4-40 μg·mL-1 with the correlation coefficient of 0.9999. The mean recovery was 98.42 % (RSD = 1.19 %). At the 60 min time point, the dissolution of paclitaxel from the solid dispersion was nearly 100 %, however, the original form of paclitaxel was about 30 %. Conclusion The method was proven to be specific, accurate and precise for determining the dissolution of paclitaxel from solid dispersion.