氯法拉滨注射液的制备及其含量测定

 目的 研究氯法拉滨注射液的处方及制备工艺，建立高效液相色谱法检测氯法拉滨注射液的含量。 方法 以稳定性为指标，筛选处方。采用 ShimPack C₁₈ (4.6 mm × 150 mm ， 5 μ m) ；以乙腈 - 水（ 10 ∶ 90 ）为流动相；检测波长为 263 nm 。 结果 ■ 本品最适 pH 值为 4.5~7.5 ，以 121 ℃热压蒸汽灭菌 15 min 作为本品的灭菌方法。氯法拉滨在 25.14 ～ 201.12 mg·L^-1 内线性关系良好，回归方程： <> Y =1 127.5<>X - 3 566.3 ， <> r =0.999 9 ），平均回收率为 99.36% ， RSD 为 0.67%( n=9) 。 结论 本品处方设计合理，工艺可行，质量稳定。所建立的高效液相色谱法简便、灵敏、准确，可作为氯法拉滨注射液含量的测定方法。

Preparation of Clofarabin Injection and Determination of Clofarabin Content

OBJECTIVE To develop an injection formulation and to establish the HPLC method for clofarabin injection.METHODS The stability of the injection was used as an indicator for screening the formulation. The samples were eluted on a Shimpack C18 (4.6 mm×150 mm, 5 μm) column with the mobile phase consisting of acetonitrile-water(10∶90) . The detection wavelength was 263 nm. RESULTS The optimum pH for the injection formulation was 4.5-7.5 according to the stability. Pressing steam stervilization was performed at 121 ℃ for 15 min. The linear range for clofarabin was from 25.14 to 201.12 mg·L-1 (Y=1 127.5X-3 566.3, r=0.999 9)，and the average recovery was 99.36% (RSD=0.67%, n=9). CONCLUSION The developed injection formulation was stable and suitable for industrial production. The assay method is rapid，simple，and accurate.