高效液相色谱法测定癸氧喹酯原料及制剂含量的研究

Study on determination of Decoquinate and its preparation by HPLC

关键词:  高效液相色谱法  癸氧喹酯  含量测定

Key words:  HPLC  decoquinate  content determination.

摘要:

拟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-紫外检测法。采用Diamonsil C18(2) 4.6?150 mm,5μm 色谱柱，以甲醇-水(95:5)溶液(用稀盐酸调pH值至3.5)为流动相，检测波长330 nm，流速为0.6 ml.min-1，外标法定量。结果显示该方法最低检测限为0.0025 μg.ml-1， 在0.5-10 μg.ml-1 浓度范围内，线性关系良好Y=11405X 15821，R2=0.9990，加样平均回收率99.61%，RSD为0.90%。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。

Abstract:

A detection method of HPLC-UV has been established for the determination of Decoquinate and its solid dispersion. A Diamonsil C18(2) column (4.6?150mm,5μm) was used with the mobile phase of methanol-water(95:5) solution(to adjust pH of 3.5 by dilute hydrochloric acid ),The UV detection wavelength was 330 nm, with a flow rate of 0.6 ml.min-1. The quantification was carried out by the external standard method. Results showed that the limit of detection of the method was 0.0025 μg.ml-1, The calibration curves have good linear over the range of 0.5~10 μg.ml-1 with the correlation coefficient of R2 =0.999 (n=6), The average recovery of Decoquinate was 99.61%, with RSD=0.90% (n=9). The all results were shown that the HPLC method may be used for the content determination of Decoquinate, applicable to the product quality control..