کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
5818733 1557333 2015 7 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Rapid communicationMicrobiological assay for the analysis of certain macrolides in pharmaceutical dosage forms
ترجمه فارسی عنوان
ارتباطات سریع ارتباط میکروبیولوژیک برای تجزیه و تحلیل برخی از ماکرولیدها در فرمهای دارویی
کلمات کلیدی
کلاریترومایسین، روکسی ترومایسین، آزمایش میکروبیولوژیک، روش بیل سیلندر، میکروکوکوس لوتئوس،
موضوعات مرتبط
علوم پزشکی و سلامت داروسازی، سم شناسی و علوم دارویی علوم دارویی
چکیده انگلیسی

Clarithromycin (CLA) and roxithromycin (ROX) are macrolide antibiotics with an expanded spectrum of activity that are commercially available as tablets. A microbiological assay, applying the cylinder-plate method and using a strain of Micrococcus luteus ATCC 9341 as test organism, has been used and validated for the quantification of two macrolide drugs; CLA and ROX in pure and pharmaceutical formulations. The validation of the proposed method was carried out for linearity, precision, accuracy and specificity. The linear dynamic ranges were from 0.1 to 0.5 μg/mL for both compounds. Logarithmic calibration curve was obtained for each macrolide (r > 0.989) with statistically equal slopes varying from 3.275 to 4.038, and a percentage relative standard deviation in the range of 0.24-0.92%. Moreover, the method was applied successfully for the assay of the studied drugs in pharmaceutical tablet dosage forms. Recovery from standard addition experiments in commercial products was 94.71-96.91% regarding clarithromycin and 93.94-98.12% regarding roxithromycin, with a precision (%RSD) 1.32-2.11%. Accordingly, this microbiological assay can be used for routine quality control analysis of titled drugs in tablet formulations.

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ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: International Journal of Pharmaceutics - Volume 491, Issues 1–2, 1 August 2015, Pages 285-291
نویسندگان
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