高效液相色谱法测定长春西汀（片）的含量及其有关物质的研究

Studies on the Assay and Determination of Related Substances of Vincocetine(Tablets)by HPLC

本文报道了用高效液相色谱法测定长春西汀（片）的含量及其有关物质的方法。采用ＹＷＧ－Ｃ_（１８）Ｈ_（３７）柱，以甲醇－碳酸铵溶液（１．５７→１０００）─乙醚（７５：２５：３）为流动相，黄体酮为内标物，用紫外检测器于２７４ｎｍ波长处测定。原料药重复性试验及片剂回收率试验的相对标准偏差均小于１．０％。长春西汀中最多可分离出５个杂质峰，其中主要杂质经对照试验初步确定为阿朴长春胺－２２－羧酸甲酯。

This paper reported the determination of vincocetine and its tablets and study on its related substance by HPLC. Chromatographic conditions were:instrument, Shimadzu LC-6A:column size,YWG-C18H37 φ4. 0mm×25cm:mobil phase. Methanol-ammonium carbonate solution (1.57→1000)-ether (75:25:3):internal standard,progesterone:now rate,1. 3ml/min:multiwavelength detector at 274nm.The RSD of the replicate test and the recovery are not more than 1.0% Five peaks of impurity can be separated from vincocetine and its tablets, The major impurity is methyl aprovincamin-22-cate.This rapid and sensitive method is suitable for quality control of vincocetine and its tablets.