کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
5137832 1494593 2017 18 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Quantification of active ingredients in semi-solid pharmaceutical formulations by near infrared spectroscopy
موضوعات مرتبط
مهندسی و علوم پایه شیمی شیمی آنالیزی یا شیمی تجزیه
پیش نمایش صفحه اول مقاله
Quantification of active ingredients in semi-solid pharmaceutical formulations by near infrared spectroscopy
چکیده انگلیسی
Near infrared (NIR) spectroscopy is increasingly gaining significance in the pharmaceutical industry for quality and in-process control. However, the potential of this method for quantitative quality control in pharmacies has long been neglected and little data is available on its application in analysis of creams and ointments. This study evaluated the applicability of NIR spectrometer with limited wavelength range (1000-1900 nm) for quantitative quality control of six different dermatological semi-solid pharmaceutical preparations. Each contained a frequently used active ingredient in a common concentration either in a water-free lipid base or in an aqueous cream matrix. Based on direct NIR transflectance measurements through standardized glass beakers and partial least squares (PLS) multivariate calibration, quantitative models were generated comparing several data pre-processing methods Whereas difficulties were observed for mixtures containing 2% (w/w) metronidazole or 4% (w/w) erythromycin, content determination was possible with sufficient accuracy for salicylic acid (5 % (w/w)) and urea (10% (w/w)) in hydrophilic as well as in lipophilic formulations meeting the limit of a maximum deviation of ± 5% (relative) from the reference values. Exemplarily, one of the methods was successfully validated according to the EMA Guideline, determining several figures of merit such as specificity, linearity, accuracy, precision and robustness.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical and Biomedical Analysis - Volume 142, 5 August 2017, Pages 178-189
نویسندگان
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