摘要
目的建立能够同时、快速、准确测定喹硫平缓释片含量及有关物质的高效液相色谱(HPLC)方法。方法色谱柱为Elite Hypersil BDS-C18柱(4.6 mm×150 mm,5μm),流动相为缓冲液(pH6.8)-甲醇(37∶63),流速1 ml/min,检测波长289 nm。结果药物浓度在0.1008～1.008 mg/ml范围内,峰面积与浓度呈线性关系,r=0.9999;该方法高、中、低浓度供试品的平均回收率均在98.0%～102.0%,RSD为0.6%;重复性及中间精密度的RSD均小于2%;检测限为0.4 ng,定量限为1.2 ng。结论该方法可以同时快速、准确地测定喹硫平缓释片的含量及有关物质。
Objective To establish an efficient and accurate HPLC method for determination of the content and related substances of quetiapine extended-release tablets.Method Elite Hypersil BDS-C18 chromatographic column（4.6 mm × 150 mm,5 μm） was used,the mobile phase consistsed of buffer solution（pH 6.8）-methanol（37∶63）,the flow rate was 1 ml/min,the wavelength for UV detection was 289 nm.Results There was a good linear relationship in the range of 0.1008-1.008 mg/ml,r=0.9999;the average recovery of the method was 98.0%-102.0%,RSD=0.6%,the reproducibility and precision were good（RSD 2%）;the detection limit of quetiapine was 0.4 ng and quantitation limit was 1.2 ng.Conclusion This HPLC method is accurate and efficient for determination of the content and related substances of quetiapine extended-release tablets.
出处
《国际药学研究杂志》
CAS
2012年第4期341-344,共4页
Journal of International Pharmaceutical Research
关键词
喹硫平缓释片
HPLC
含量测定
有关物质
quetiapine extended-release tablet
HPLC
content determination
related substances
