高效液相色谱法测定癸氧喹酯原料及制剂含量的研究

建立了癸氧喹酯原料药、固体分散体含量测定的高效液相色谱一紫外检测法。采用DiamonsilC18（4．6mm×150mm，5μm）反相色谱柱，以甲醇一水（95：5）溶液（用稀盐酸调pH值至3．5）为流动相，检测波长330nm，流速0．6mL／min，外标法定量。结果显示该方法最低检测限为0．0025p,g／mL，在0．5～10斗μmL浓度范围内，线性关系良好（A=11405C＋15821，R=0．999），加样平均回收率99．61％，RSD为0．90％。此方法可用于癸氧喹酯的含量测定，适用于该药品固体分散体生产的质量控制。

Study on determination of Decoquinate and its preparation by HPLC

A detection method of HPLC-UV was established for determination of decoquinate and its solid dispersion preparation.Diamonsil C18 column(4.6 mm×150 mm,5 μm) was used with the mobile phase of methanol-water(95∶5) solution(to adjust pH value of 3.5 by dilute hydrochloric acid),The UV detection wavelength was 330 nm with flow rate of 0.6 mL/min.The quantification was carried out by the external standard method.Results showed that the limit of detection method was 0.0025 μg/mL.The calibration curves had good linearity within the concentration range of 0.5~10 μg/mL with the correlation coefficient of 0.999(n=6).The average recovery of decoquinate was 99.61% with RSD of 0.90%(n=9).The all above-mentioned results indicated that the HPLC method can be used for content determination of decoquinate and was applicable to product quality control of its solid dispersion preparation.