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Наслов: Fast and selective HPLC-DAD method for determination of pholcodine and related substances
Authors: Petkovska, Ana
Babunovska, Hristina
Stefova, Marina 
Issue Date: 5-дек-2011
Publisher: Society of Chemists and Technologists of Macedonia
Journal: Macedonian Journal of Chemistry and Chemical Engineering
Abstract: <jats:p>Quality control of pharmaceuticals requires development of fast, efficient and reliable methods for determination of active compounds as well as known and very often unknown impurities within defined concentration ranges. In this work, a simple and rapid HPLC-UV-DAD method for identification and quantification of pholcodine process related impurities and some degradation products was developed and validated. Pholcodine and its five structural analogues such as morphine, codeine, thebaine, oripavine, and papaverine were separated in less than 10 minutes using reversed phase LiChrospher C-8 column. For optimal chromatographic performance with reproducible retention times, gradient elution with 2% ammonium hydroxide in water and acetonitrile was used. The method was validated by establishing its selectivity, specifity, sensitivity, linearity, intra- and inter-day precision and robustness. All tested parameters confirmed that the method is suitable for determination of pholcodine and its five impurities in pharmaceutical drug samples. The results obtained from real sample analysis give support to the suitability of the proposed method for the purpose of quality control.</jats:p>
URI: http://hdl.handle.net/20.500.12188/14971
Appears in Collections:Faculty of Natural Sciences and Mathematics: Journal Articles

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XIII_1764.pdfA. Petkovska, H. Babunovska, M. Stefova, Fast and selective HPLC-DAD method for determination of pholcodine and related substances, Macedonian Journal of Chemistry and Chemical Engineering, 30(2), 139–149 (2011).1.44 MBAdobe PDFView/Open
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