高效液相色谱法测定苯丙氨酯原料及其片剂中的有关物质

Determination of the related substances in phenprobamate and its tablets by HPLC

关键词:  高效液相色谱法  苯丙氨酯  原料  片剂  有关物质

Key words:  HPLC  phenprobamate  raw materia  tablets  related substance

摘要:

为了建立苯丙氨酯原料及其片剂中有关物质含量的测定方法，本研究采用SunFire 100-5C18色谱柱进行测定，测定条件以甲醇∶水（50∶50，V∶V）为流动相，流速1 mL·min^-1，检测波长259 nm，室温30℃。研究结果显示，苯丙氨酯与其有关物质能分离完全，氨基甲酸苄酯、苯丙醇和苯丙氨酯在各自的质量浓度范围内线性关系良好（r≥0.999），平均回收率分别为98.2%、102.0%、100.9%（n=9）。本方法操作简便，准确，灵敏度高，重现性好，可作为苯丙氨酯原料及其片剂的有关物质测定方法。

Abstract:

An HPLC method was established for the content determination of the related substances in phenprobamate and its tablets.A SunFire C18 column was used as chromatographic column.The measurement conditions were that the mobile phase was methanol:water (50:50,V:V),the flow rate was 1.0 mL·min^-1,the detection wavelength was set at 259 nm and the column temperature was maintained at 30℃.The results show that phenprobamate and its related substances can be completely separated,and the linear relationship between benzyl carbamate,phenylpropanol and phenprobamate in their mass concentration ranges is good (r ≥ 0.999),and the average recovery rate is 98.2%,102.0%,100.9% (n=9),respectively.The established method is simple,accurate,with high sensitivity,and reproducible,so it can be used for simultaneous determination of the related substances in phenprobamate raw materials and its tablets.