盐酸氯环利嗪有关物质的测定
发布时间：2018-10-23 13:46
【摘要】：建立了高效液相色谱法配合气相色谱法测定盐酸氯环利嗪的有关物质。采用GC法测定己知有关物质N-甲基哌嗪。使用Rtx-1毛细管色谱柱,程序升温,氢火焰离子化检测器。N-甲基哌嗪在10~100μg/ml浓度范围内线性关系良好,平均回收率为99.3%,RSD为1.3%,最低检测限为0.22μ.g/ml。采用HPLC法测定其他未知有关物质。使用C_(18)色谱柱,以乙腈:0.01 mol/L磷酸二氢钾溶液(含0.4%三乙胺,用磷酸调至pH 3.5)(35:65)为流动相,检测波长231 nm,盐酸氯环利嗪与降解产物能有效分离。
[Abstract]:A high performance liquid chromatography (HPLC) combined with gas chromatography (GC) was established for the determination of the related substances of chlorcycloprazine hydrochloride. N-methyl piperazine was determined by GC. Using Rtx-1 capillary column, programmed temperature, hydrogen flame ionization detector, the linear range of N- methylpiperazine was 10 ~ 100 渭 g/ml, the average recovery was 99.3% and the lowest detection limit was 0.22 渭 g / ml. Other unknown related substances were determined by HPLC method. Using C18 column, acetonitrile: 0.01 mol/L potassium dihydrogen phosphate solution (containing 0.4% triethylamine, adjusted to pH 3.5 with phosphoric acid) (35:65) was used as mobile phase. The detection wavelength was 231 nm, and chlorcizine hydrochloride and degradation product could be separated effectively.
【作者单位】： 河南省食品药品检验所;焦作福瑞堂制药有限公司;
【分类号】：R927.1
本文编号：2289438
[Abstract]:A high performance liquid chromatography (HPLC) combined with gas chromatography (GC) was established for the determination of the related substances of chlorcycloprazine hydrochloride. N-methyl piperazine was determined by GC. Using Rtx-1 capillary column, programmed temperature, hydrogen flame ionization detector, the linear range of N- methylpiperazine was 10 ~ 100 渭 g/ml, the average recovery was 99.3% and the lowest detection limit was 0.22 渭 g / ml. Other unknown related substances were determined by HPLC method. Using C18 column, acetonitrile: 0.01 mol/L potassium dihydrogen phosphate solution (containing 0.4% triethylamine, adjusted to pH 3.5 with phosphoric acid) (35:65) was used as mobile phase. The detection wavelength was 231 nm, and chlorcizine hydrochloride and degradation product could be separated effectively.
【作者单位】： 河南省食品药品检验所;焦作福瑞堂制药有限公司;
【分类号】：R927.1
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