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采用反相高效液相色谱/脉冲安培检测法同时测定剂型及加标人血浆中共同给药的地夫可特、阿瑞匹坦和格拉司琼。

Simultaneous Determination of Co-administrated Deflazacort, Aprepitant and Granisetron in Dosage Forms and Spiked Human Plasma by RP-HPLC/PAD.

作者信息

Tantawy Mahmoud A, Alweshahy Soheir, Elshabasy Dalia A, Youssef Nadia F

机构信息

Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El-Aini St., Cairo 11562, Egypt.

Pharmaceutical Chemistry Department, National Organization for Drug Control and Research, 6 Abu Hazem St., Pyramids Avenue, P.O. 29, Giza, Egypt.

出版信息

J Chromatogr Sci. 2019 Oct 17;57(9):790-798. doi: 10.1093/chromsci/bmz062.

DOI:10.1093/chromsci/bmz062
PMID:31504281
Abstract

A selective reversed phase high performance liquid chromatography/photodiode array detector (RP-HPLC/PAD) method has been developed for simultaneous determination of the three co-administrated deflazacort, aprepitant and granisetron drugs used with chemotherapy. The three cited drugs have been chromatographed on C18 column using a mobile phase consisting of acetonitrile-0.2% v/v triethylamine (80:20 v/v, pH of 6.6 ± 0.05) with isocratic elution and monitored by photodiode array at 220 nm. International conference on harmonization (ICH) guidelines were followed to validate the developed method. Successful application of the developed method was assessed by the simultaneous determination of the studied drugs in pure forms, dosage forms and plasma samples in the ranges of 0.2-20, 0.4-40 and 0.2-20 μg/mL for deflazacort, aprepitant and granisetron, respectively.

摘要

已开发出一种选择性反相高效液相色谱/光电二极管阵列检测器(RP-HPLC/PAD)方法,用于同时测定三种与化疗联用的共同给药药物——地夫可特、阿瑞匹坦和格拉司琼。上述三种药物在C18柱上进行色谱分析,使用由乙腈-0.2%(v/v)三乙胺(80:20 v/v,pH为6.6±0.05)组成的流动相进行等度洗脱,并通过光电二极管阵列在220 nm波长下进行监测。遵循国际协调会议(ICH)指南对所开发的方法进行验证。通过分别在0.2-20、0.4-40和0.2-20μg/mL范围内同时测定纯品、剂型和血浆样品中的研究药物,评估所开发方法的成功应用情况,其中地夫可特、阿瑞匹坦和格拉司琼的浓度范围分别为上述数值。

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