کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
10553670 | 967888 | 2009 | 6 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Validated UPLC method for the fast and sensitive determination of steroid residues in support of cleaning validation in formulation area
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موضوعات مرتبط
مهندسی و علوم پایه
شیمی
شیمی آنالیزی یا شیمی تجزیه
پیش نمایش صفحه اول مقاله
![عکس صفحه اول مقاله: Validated UPLC method for the fast and sensitive determination of steroid residues in support of cleaning validation in formulation area Validated UPLC method for the fast and sensitive determination of steroid residues in support of cleaning validation in formulation area](/preview/png/10553670.png)
چکیده انگلیسی
An ultra performance liquid chromatographic (UPLC) method was developed for simultaneous determination of seven steroid (dienogest, finasteride, gestodene, levonorgestrel, estradiol, ethinylestradiol, and norethisterone acetate) active pharmaceutical ingredient (API) residues. A new, generic method is presented, with which it is possible to verify the cleaning process of a steroid producing equipment line used for the production of various pharmaceuticals. The UPLC method was validated using an UPLC⢠BEH C18 column with a particle size of 1.7 μm (50 mm Ã 2.1 mm) and acetonitrile-water (48:52, v/v) as mobile phase at a flow rate of 0.55 ml/min. Method development and method validation for cleaning control analysis are described. The rapid UPLC method is suitable for cleaning control assays within good manufacturing practices (GMP) of the pharmaceutical industry.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical and Biomedical Analysis - Volume 49, Issue 3, 5 April 2009, Pages 833-838
Journal: Journal of Pharmaceutical and Biomedical Analysis - Volume 49, Issue 3, 5 April 2009, Pages 833-838
نویسندگان
Szabolcs Fekete, JenÅ Fekete, Katalin Ganzler,