کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
10553643 | 967888 | 2009 | 9 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Development and validation of a stability-indicating RP-HPLC method to separate low levels of dexamethasone and other related compounds from betamethasone
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کلمات کلیدی
موضوعات مرتبط
مهندسی و علوم پایه
شیمی
شیمی آنالیزی یا شیمی تجزیه
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چکیده انگلیسی
Betamethasone (BM) is an active pharmaceutical ingredient (API) or an intermediate which is used to manufacture various finished pharmaceutical products. Betamethasone is also used as a starting material to manufacture other APIs that are related to this steroid family. It is quite a challenging task to separate dexamethasone (DM) peak (the alpha epimer) and other structurally related compounds from BM. A stability-indicating reversed-phase high performance liquid chromatography (RP-HPLC) method has been developed which can separate and accurately quantitate low levels of DM and other related compounds from BM and also from each other. This method was successfully validated for the purpose of conducting stability studies of betamethsone in quality control (QC) laboratories. The stability-indicating capability of this method was demonstrated by adequate separation of DM and all the degradation product peaks from BM peak and also from each other in aged stability samples of betamethasone. A gradient mobile phase system consisting of (A) water:acetonitrile (90:10, v/v) and (B) acetonitrile:isopropanol (80:20, v/v) was used with an ACE Phenyl column (10 cm Ã 4.6 mm, 3 μm particles, 100 Ã
pore size) and an ultraviolet (UV) detection at 240Â nm.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical and Biomedical Analysis - Volume 49, Issue 3, 5 April 2009, Pages 646-654
Journal: Journal of Pharmaceutical and Biomedical Analysis - Volume 49, Issue 3, 5 April 2009, Pages 646-654
نویسندگان
Yuan Xiong, Kang Ping Xiao, Abu M. Rustum,