RP-HPLC法测定他克莫司聚酸酐纳米制剂中他克莫司的含量

Determination of content of tacrolimus in polyanhydride nanoparticles by RP-HPLC

目的建立他克莫司聚酸酐纳米制剂的含量测定方法。方法采用RP-HPLC法。色谱柱为以十八烷基硅烷键合硅胶为填充剂的Kromasil-C18柱(250 mm×4.6 mm,5μm),流动相为乙腈-水(体积比为90:10),流速为1.0 mL·min-1,检测波长为216 nm,柱温为60℃,进样量为20μL。对3批自制他克莫司聚酸酐纳米制剂进行含量测定。结果他克莫司在2.0~200.4 mg·L-1内与吸收峰面积呈良好的线性关系(r=0.999 9),回归方程为A=12 530ρ-1 641.4,最低定量限为0.5 mg·L-1,平均回收率(n=9)为100.1%,RSD为1.18%。3批自制他克莫司聚酸酐纳米制剂的含量分别为866.3、876.3、878.3 mg·L-1。结论该方法可用于测定他克莫司聚酸酐纳米制剂的含量。

Objectives To establish an RP-HPLC method for the determination of tacrolimus in polyanhydride nanoparticles. Methods RP-HPLC method was adopted. Kromasil-ODS(250 mm×4.6 mm, 5 μm)column was used. The mobile phase consisted of acetonitrile-water(V:V=90:10). The flow rate was1.0 mL·min-1 and the detection wavelength was set at 216 nm. The column temperate was 60℃. The sample volume was 20 μL. The contents of tacrolimus in 3 batches polyanhydride nanoparticles were determined. Results Good linear correlation(r=0.999 9) between peak areas(A) and concentration(ρ) of tacrolimus ranging from 2.0 to 200.4 mg·L-1 was obtained, and the calibration curve was A=12 530 ρ-1 641.4. The lower limit of quantitation(LLOQ) for tacrolimus was 0.5 mg·L-1. The average recovery was 100.1%(n=9) and RSD was 1.18%. The contents of tacrolimus in 3 batches of polyanhydride nanoparticles were 866.3,876.3,878.3 mg·L-1, respectively. Conclusions RP-HPLC method established here was competent for the assay of tacrolimus in polyanhydride nanoparticles.