HPLC-UV定量人血浆中CDK4/6抑制剂的新方法的建立与验证

IF 0.4 Q3 MEDICINE, GENERAL & INTERNAL Current Issues in Pharmacy and Medical Sciences Pub Date : 2023-06-01 DOI:10.2478/cipms-2023-0014
Rakesh U. Shelke, Dinesh D. Rishipathak
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引用次数: 1

摘要

摘要:建立了一种高效液相色谱紫外/可见光检测(HPLC-UV)定量加标人血浆中核糖西尼(Ribociclib)的方法。首先用乙腈进行简单的蛋白沉淀萃取,从血浆样品中提取核糖环尼(RCB)和内标物Trifluridine。采用Orochem orosil C18 (4.6 mm × 250 mm, 5 μ)反相色谱法分析血浆中RCB和内标物的浓度,以10 mm磷酸盐缓冲液-乙腈(60:40,v/v)为等温流动相,流速为1.0 ml/min,洗脱至pH 3.0。随后在260 nm波长下对RCB和IS进行检测。定量限为10 ng/ml。在10 ~ 1000 ng/ml的浓度范围内,校准曲线呈线性(R2>0.998)。对于人血浆,除定量下限在≤20%以内外,所有浓度的准确度和精密度分别在±15%和≤15%以内。
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Development and validation of a new bioanalytical method for quantification of CDK4/6 inhibitor in Spiked Human Plasma by HPLC-UV
Abstract A sensitive and accurate high performance liquid chromatography method utilizing ultraviolet/visible light detection (HPLC-UV) for the quantification of Ribociclib in Spiked Human Plasma by HPLC-UV was developed and validated. Ribociclib (RCB) and the internal standard (IS), Trifluridine, were first extracted from plasma samples by a simple Protein Precipitation extraction using Acetonitrile. Plasma concentration of RCB and internal standard were then analyzed by applying reversed phase chromatography using Orochem orosil C18 (4.6 mm × 250 mm, 5 μ) and elution with a isocratic mobile phase consisting of 10 mM phosphate buffer – Acetonitrile (60:40, v/v) adjusted to pH 3.0 at a flow rate of 1.0 ml/min. Detection of RCB and the IS was subsequently done at a wavelength of 260 nm. The limit of quantification was 10 ng/ml. The calibration curve was linear (R2>0.998) over the concentration range of 10-1000 ng/ml. For human plasma, the accuracy and precision were within ±15% and ≤15%, respectively, for all concentrations, except for the lower limit of quantification, where they were within ≤20%.
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来源期刊
Current Issues in Pharmacy and Medical Sciences
Current Issues in Pharmacy and Medical Sciences MEDICINE, GENERAL & INTERNAL-
CiteScore
0.80
自引率
0.00%
发文量
28
审稿时长
16 weeks
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