کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
1224944 | 967940 | 2006 | 8 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
LC/MS/MS method for the determination of trace amounts of cefmetazole and cefpodoxime proxetil contaminants in pharmaceutical manufacturing environments
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کلمات کلیدی
موضوعات مرتبط
مهندسی و علوم پایه
شیمی
شیمی آنالیزی یا شیمی تجزیه
پیش نمایش صفحه اول مقاله
![عکس صفحه اول مقاله: LC/MS/MS method for the determination of trace amounts of cefmetazole and cefpodoxime proxetil contaminants in pharmaceutical manufacturing environments LC/MS/MS method for the determination of trace amounts of cefmetazole and cefpodoxime proxetil contaminants in pharmaceutical manufacturing environments](/preview/png/1224944.png)
چکیده انگلیسی
In this study, a selective and sensitive LC/MS/MS method for the determination of trace amounts of cefmetazole (CMZ) and cefpodoxime proxetil (CPDXPR) contaminants in manufacturing environments was developed. The necessary sensitivity of this method was estimated based on the detection limit for Penicillin G required by the FDA and the total surface area and volume of the manufacturing facility. The detection limits of this method were estimated to be 10Â pg/ml for CMZ and 5Â pg/ml for CPDXPR from the signal to noise ratio and as a result satisfactory sensitivity was achieved. The method was linear in a concentration range from 0.20 to 3.20Â ng/ml. The accuracy and precision were verified by the determination of the amount of CMZ and CPDXPR added to the sampling materials, a glass plate and a silica fiber filter. The mean recoveries of nine replicated determinations from the glass plate were 99.1% with 5.58%R.S.D. for CMZ and 97.1% with 3.80%R.S.D. for CPDXPR, and those from the silica fiber filter were 100.7% with 4.50%R.S.D. for CMZ and 95.4% with 2.85%R.S.D. for CPDXPR. This method has been successfully applied to the determination of CMZ and CPDXPR contaminants in samples collected from an actual manufacturing environment.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical and Biomedical Analysis - Volume 41, Issue 4, 16 June 2006, Pages 1243-1250
Journal: Journal of Pharmaceutical and Biomedical Analysis - Volume 41, Issue 4, 16 June 2006, Pages 1243-1250
نویسندگان
Naoto Fukutsu, Yuichi Sakamaki, Takao Kawasaki, Koichi Saito, Hiroyuki Nakazawa,