摘要:
目的: 建立液相色谱-串联质谱(LC/MS/MS)测定片剂中的卡马西平含量的方法。 方法: 色谱柱Zorbax Ex-tend-C18柱(150 mm×4.6 mm,5μm);流动相:甲醇-0.01 mmol/l乙酸胺溶液(80:20,v/v);流速:0.3 ml/min。 结果: 卡马西平浓度在0.05～40μg/ml范围内,峰面积与浓度线性关系良好,平均回收率为100.2%,RSD为1.02%。日内精密度、日间精密度的RSD分别为1.72%和1.91%。4批样品中卡马西平的含量分别为96.3%、98.6%、96.5%、99.0%。 结论: 本方法:具有良好的灵敏度、准确度、精确度及专属性,结果准确,重现性好,易于操作,可用于制剂中卡马西平含量的测定。
Abstract:
Objective To develop liquid chromatography with tandem mass spectrometry(LC-MS/MS) detection for the content determination of carbamazepine tablet. Methods The method was used.The sample was analyzed on Zorbax Extend-C18(150 mm×4.6 mm,5 μm),with mobile phase consisting of methanol-0.01 mmol/l amine acetic acid(80:20,v/v) at a flow rate of 0.3 ml/min. Results It was proved to be linear in the range of 0.05～40 μg/ml with a regression coefficient of 0.999 4.The average recovery rate was 100.2%(n=5) and RSD was 1.02%.The RSD of average contents of intra-day and inter-day was 1.72% and 1.91% respectively.The concentrations of four lot samples were 96.3%,98.6%,96.5% and 99.0%,respectively. Conclusion This method is accurate,precise,sensitive and specific to be used in the content determination of carbamazepine tablet.
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