高效液相色谱法测定右旋噻吗洛尔及其对映体含量

High performance liquid chromatography determination of d-timolol and its enantiomer content

目的 :建立右旋噻吗洛尔含量测定、有关物质检查及对映体纯度检查方法。方法 :采用高效液相色谱法 ,以DiamonsilTM C18柱测定噻吗洛尔含量及有关物质 ;以CyclobondI 2 0 0 0 TM 柱检查右旋噻吗洛尔对映体纯度。结果 :噻吗洛尔与其中间体及降解产物之间分离良好 ;噻吗洛尔在 0～ 5 0 0mg·L- 1浓度范围内符合线性关系 ,日内、日间测定的相对标准偏差均小于 0 .6 % ;右旋噻吗洛尔与其左旋对映体可完全分离 (Rs>2 .4 )。结论 :建立的方法快速简便、准确可靠 。

AIM:To establish an assay method for the determination of d timolol, its related substances and enantiomer purity. METHODS: HPLC method was used to determine timolol and its related substances on a Diamonsil TM C 18 column, while enantiomer impurity was inspected on a Cyclobond I 2000 TM column. RESULTS: Perfect resolution had been achieved among timolol, its related substances and degradated products. The assay of timolol showed good linearity over the concentration range of 0 500 mg·L -1 , and its inter day and intra day RSD were all less than 0.6 %. The resolution of the two enantiomers was greater than 2.4. CONCLUSION:The method is simple and accurate to control the quality of d timolol.