Department of Pharmaceutical Sciences, Jawaharlal Nehru Technological University Kakinada, Kakinada 533 003, India ; Department of Pharmaceutical Analysis and Pharmacology, Geethanjali College of Pharmacy, Cheeryal, Hyderabad 501 301, India.
Department of Chemistry, Yogi Vemana University, Kadapa 516 003, India.
J Adv Res. 2015 Nov;6(6):931-40. doi: 10.1016/j.jare.2014.08.010. Epub 2014 Sep 6.
The liquid chromatography-tandem mass spectrometric assay method for the simultaneous determination of rosuvastatin and amlodipine in human plasma using deuterated analogs as internal standards has been developed and validated. The analytes were extracted from 100 μL aliquots of human plasma via liquid-liquid extraction using a mixture of ethyl acetate and n-hexane (80:20, v/v) as an extraction solvent. The optimized mobile phase was composed of 0.1% formic acid in 5 mM ammonium acetate, methanol, and acetonitrile (20:20:60, v/v/v) and delivered at a flow rate of 0.75 mL/min. The calibration curve obtained was linear (R (2) ⩾ 0.999) over the concentration range of 0.52-51.77 ng/mL for rosuvastatin and 0.10-10.07 ng/mL for amlodipine. A sample turnover rate of less than 2.5 min makes it an attractive procedure in high-throughput bioanalysis of rosuvastatin and amlodipine. The present method was found to be applicable to clinical studies and the results were authenticated by incurred sample reanalysis.
建立并验证了一种采用氘代类似物作为内标物，同时测定人血浆中罗苏伐他汀和氨氯地平的液相色谱-串联质谱分析方法。通过液-液萃取，用乙酸乙酯和正己烷（80:20，v/v）的混合物作为萃取溶剂，从 100 μL 人血浆等分试样中提取分析物。优化后的流动相由 0.1%甲酸、5mM 乙酸铵、甲醇和乙腈（20:20:60，v/v/v）组成，流速为 0.75 mL/min。罗苏伐他汀的浓度范围为 0.52-51.77ng/mL 时，得到的校准曲线呈线性（R 2 ⩾0.999）；氨氯地平的浓度范围为 0.10-10.07ng/mL 时，也呈线性。该方法的样品周转时间小于 2.5 分钟，在高通量的罗苏伐他汀和氨氯地平生物分析中具有吸引力。通过对回收样品的重新分析验证了该方法的适用性。
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