评估测定阿比特龙 pKa 的 RP-LC 方法及其检测方法

IF 1.7 4区化学 Q3 CHEMISTRY, ANALYTICAL

Acta Chromatographica Pub Date : 2023-12-29 DOI:10.1556/1326.2023.01173

S. Şanlı, M. Şahin, Ayşe Özdemir, Buket Paşa

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引用次数: 0

摘要

我们设计了一种简单、可靠、快速的 RP-LC 方法，用于分析醋酸阿比特龙的剂型和人体尿液。该方法采用 DAD 检测，灵敏度高。该方法的 LOD 和 LOQ 均符合要求。根据 ICH 的要求，对所建议的方法进行了详尽的验证，结果表明该方法在分析该药物时准确、精确、选择性强且灵敏度高。色谱分离采用 X-Terra RP-18 色谱柱（150 × 4.60 mm i.d. × 5 μm）和紫外检测器（255 和 267 nm）。此外，还根据保留因子与流动相 pH 值之间的关系计算了 pKa 值。通过测量 50% 至 70% (v/v) 不同乙腈-水组合下的 pKa 值，研究了流动相组成对电离常数的影响。

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Evaluation of the RP-LC method for determining the pKa of abiraterone and its assay

A straightforward, dependable, and quick RP-LC method for the analysis of abiraterone acetate in its dose form and human urine has been devised. With DAD detection, sensitivity was reported to be high. The LOD and LOQ of the procedure were deemed adequate. The suggested approach was exhaustively validated in accordance with ICH requirements, and the findings demonstrated that it was exact, accurate, selective, and sensitive for the analysis of this pharmaceutical. The chromatographic separation was realized using a X-Terra RP-18 (150 × 4.60 mm i.d. × 5 μm) column and a UV detector set at 255 and 267 nm. In addition, pKa values were calculated based on the relationship between the retention factor and the pH of the mobile phase. The influence of the composition of the mobile phase on the ionization constant was investigated by measuring the pKa at various acetonitrile–water combinations ranging from 50 to 70% (v/v).

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来源期刊

Acta Chromatographica 化学-分析化学

CiteScore

4.00

自引率

0.00%

发文量

审稿时长

2.3 months

期刊介绍： Acta Chromatographica Open Access Acta Chromatographica publishes peer-reviewed scientific articles on every field of chromatography, including theory of chromatography; progress in synthesis and characterization of new stationary phases; chromatography of organic, inorganic and complex compounds; enantioseparation and chromatography of chiral compounds; applications of chromatography in biology, pharmacy, medicine, and food analysis; environmental applications of chromatography; analytical and physico-chemical aspects of sample preparation for chromatography; hyphenated and combined techniques; chemometrics and its applications in separation science.