کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
9754463 | 1494678 | 2005 | 5 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
A validated HPLC stability-indicating method for the determination of diacerhein in bulk drug substance
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کلمات کلیدی
موضوعات مرتبط
مهندسی و علوم پایه
شیمی
شیمی آنالیزی یا شیمی تجزیه
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چکیده انگلیسی
A novel stability-indicating high-performance liquid chromatographic (HPLC) method was developed and validated for the assay of diacerhein in bulk forms. Diacerhein was found to degrade in alkaline and acidic conditions and also under oxidative stress. The drug was stable to dry heat and in presence of light. Resolution of drug, its potential impurities and degradation products were achieved on a RP18 (endcapped) column utilizing 0.1Â M phosphoric acid and methanol (40:60, v/v) as eluent at the detection wavelength of 254Â nm. The validation studies were carried out fulfilling International Conference on Harmonisation (ICH) requirements. The procedure was found to be specific, linear, precise (including intermediate precision), accurate and robust.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical and Biomedical Analysis - Volume 39, Issues 3â4, 15 September 2005, Pages 776-780
Journal: Journal of Pharmaceutical and Biomedical Analysis - Volume 39, Issues 3â4, 15 September 2005, Pages 776-780
نویسندگان
Valerio Giannellini, Francesco Salvatore, Gianluca Bartolucci, Silvia A. Coran, Massimo Bambagiotti-Alberti,