A new high-performance liquid chromatography (HPLC) method for the analysis of halofantrine (HF) in pharmaceuticals.
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.
Abdul-Fattah
Ahmad M
AM
Department of Pharmaceutical Sciences, Massachusetts College of Pharmacy and Health Sciences, Boston, MA 02115, USA.
Bhargava
Hridaya N
HN
D000962:Antimalarials / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D010616:Phenanthrenes / Q000032:analysis*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
D000962:Antimalarials; D004364:Pharmaceutical Preparations; D010616:Phenanthrenes; C023768:halofantrine