Nirogi Ramakrishna, Bhyrapuneni Gopinadh, Kandikere Vishwottam, Mudigonda Koteshwara, Ajjala Devender, Suraneni Ramakrishna, Mukkanti K
Pharmacokinetics and Drug Metabolism, Drug Discovery, Suven Life Sciences Ltd, Serene Chambers, Road 5, Avenue 7, Banjara Hills, Hyderabad 500034, India.
Biomed Chromatogr. 2008 Dec;22(12):1424-33. doi: 10.1002/bmc.1076.
A sensitive and selective high-performance liquid chromatography-positive ion electrospray tandem mass spectrometry method was developed and validated for the quantification of amisulpride in 100 microL of human plasma. Following liquid-liquid extraction, the analytes were separated using an isocratic mobile phase on a reverse-phase column and analyzed by MS/MS in the multiple reaction monitoring mode using the respective (M + H)(+) ions, m/z 370-242 for amisulpride and m/z 341-112 for the internal standard. The assay exhibited a linear dynamic range with a lower range of 0.1-100 ng/mL and a higher range of 1-500 ng/mL of amisulpride in human plasma. The lower limit of quantification was 0.1 ng/mL with a relative standard deviation of less than 10%. Acceptable precision and accuracy were obtained for both linearity ranges. A run time of 2.0 min for each sample made it possible to analyze more than 275 human plasma samples per day. The validated method has been successfully used to analyze plasma samples for application in pharmacokinetic studies.
建立了一种灵敏且具选择性的高效液相色谱 - 正离子电喷雾串联质谱法,并验证了其用于定量检测100微升人血浆中氨磺必利的能力。液 - 液萃取后,使用等度流动相在反相柱上分离分析物,并采用多反应监测模式通过MS/MS进行分析,使用各自的(M + H)(+)离子,氨磺必利的m/z为370 - 242,内标的m/z为341 - 112。该测定法在人血浆中氨磺必利的线性动态范围呈现为较低范围0.1 - 100 ng/mL和较高范围1 - 500 ng/mL。定量下限为0.1 ng/mL,相对标准偏差小于10%。两个线性范围均获得了可接受的精密度和准确度。每个样品的运行时间为2.0分钟,使得每天能够分析超过275份人血浆样品。该经过验证的方法已成功用于分析血浆样品,以应用于药代动力学研究。