کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
1220575 1494615 2016 10 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
An iterative approach for compound detection in an unknown pharmaceutical drug product: Application on Raman microscopy
ترجمه فارسی عنوان
یک رویکرد تکراری برای تشخیص ترکیب در یک محصول دارویی ناشناخته: کاربرد در میکروسکوپ رامان
کلمات کلیدی
میکروسکوپ رامان، طرح بندی ارتوگنال، نقشه برداری طیفی، شناسایی، ترکیب کم دوز
موضوعات مرتبط
مهندسی و علوم پایه شیمی شیمی آنالیزی یا شیمی تجزیه
چکیده انگلیسی


• Development of an iterative approach for pure compound identification.
• Detection of a low dose compound in a drug product.
• Application of multivariate curve resolution to study the compound distributions.

Raman chemical imaging provides both spectral and spatial information on a pharmaceutical drug product. Even if the main objective of chemical imaging is to obtain distribution maps of each formulation compound, identification of pure signals in a mixture dataset remains of huge interest. In this work, an iterative approach is proposed to identify the compounds in a pharmaceutical drug product, assuming that the chemical composition of the product is not known by the analyst and that a low dose compound can be present in the studied medicine. The proposed approach uses a spectral library, spectral distances and orthogonal projections to iteratively detect pure compounds of a tablet. Since the proposed method is not based on variance decomposition, it should be well adapted for a drug product which contains a low dose product, interpreted as a compound located in few pixels and with low spectral contributions. The method is tested on a tablet specifically manufactured for this study with one active pharmaceutical ingredient and five excipients. A spectral library, constituted of 24 pure pharmaceutical compounds, is used as a reference spectral database. Pure spectra of active and excipients, including a modification of the crystalline form and a low dose compound, are iteratively detected. Once the pure spectra are identified, multivariate curve resolution-alternating least squares process is performed on the data to provide distribution maps of each compound in the studied sample. Distributions of the two crystalline forms of active and the five excipients were in accordance with the theoretical formulation.

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ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical and Biomedical Analysis - Volume 120, 20 February 2016, Pages 342–351
نویسندگان
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