کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
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1223721 | 967899 | 2009 | 5 صفحه PDF | دانلود رایگان |
A high performance liquid chromatography (HPLC) method was developed to quantify free fatty acids (FFA) in a pharmaceutical suspension formulated with phospholipids as stabilizing agents. Specifically, a suspension of crystalline itraconazole microparticles stabilized with Lipoid E80 was used as a model system to study the physicochemical stability of an aqueous, phospholipid-based suspension for injection. The hydrolysis of the phospholipids during storage at elevated temperatures (40 °C) necessitated the development of a suitable HPLC method for the determination of free fatty acid content in the suspension samples.HPLC methods using two types of aerosol detectors were investigated for the above purpose. Reversed-phase separation coupled with either an evaporative light scattering detector (ELSD) or a CoronaPlus charged aerosol detector (CAD) was used. A comparison of the methods indicated that the CAD method provided better sensitivity, precision, recovery, and linearity for the parameters evaluated. As a result, this method was chosen for the stability study of itraconazole suspension and has been incorporated in subsequent formulation studies.
Journal: Journal of Pharmaceutical and Biomedical Analysis - Volume 49, Issue 1, 15 January 2009, Pages 95–99