一种用于分析药物中卤泛群（HF）的新型高效液相色谱（HPLC）方法。
A new high-performance liquid chromatography (HPLC) method for the analysis of halofantrine (HF) in pharmaceuticals.
作者信息
Abdul-Fattah Ahmad M, Bhargava Hridaya N
机构信息
Department of Pharmaceutical Sciences, Massachusetts College of Pharmacy and Health Sciences, Boston, MA 02115, USA.
出版信息
J Pharm Biomed Anal. 2002 Jul 31;29(5):901-8. doi: 10.1016/s0731-7085(02)00198-x.
A simple, rapid and stability-indicating reverse-phase high-performance liquid chromatography (HPLC) method was developed for the assay of halofantrine (HF) base, 1,3-dichloro-alpha-[2-(dibutylamino)ethyl]-6-(trifluoromethyl)-9-phenanthrenemethanol. The HPLC method was validated for precision, accuracy, selectivity and linearity and range. It was used to assay for HF base in solid dispersions. Excellent linearity was observed between HF base concentration and the peak area (R(2)=0.9998). The limit of detection was 1 ng (with a signal-to-noise ratio of 2:1), and the limit of quantitation was 10 ng (with a signal-to-noise ratio of 10:1). The method proved to be selective. Selectivity was validated by subjecting a stock solution of HF to acidic, basic, oxidative and thermal degradations. The peaks of the degradation products did not interfere with the peak of HF. Excipients present in the solid dispersions did not interfere with the analysis.
建立了一种简单、快速且具有稳定性指示作用的反相高效液相色谱（HPLC）法，用于测定卤泛群（HF）碱，即1,3 - 二氯 - α - [2 - （二丁基氨基）乙基] - 6 - （三氟甲基）- 9 - 菲甲醇。该HPLC法在精密度、准确度、选择性以及线性和范围方面均经过验证。它被用于测定固体分散体中的HF碱。观察到HF碱浓度与峰面积之间具有出色的线性关系（R(2)=0.9998）。检测限为1 ng（信噪比为2:1），定量限为10 ng（信噪比为10:1）。该方法具有选择性。通过对HF储备溶液进行酸、碱、氧化和热降解来验证选择性。降解产物的峰不干扰HF的峰。固体分散体中存在的辅料不干扰分析。
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