期刊
JOURNAL OF CHROMATOGRAPHY A
卷 1218, 期 37, 页码 6439-6447出版社
ELSEVIER
DOI: 10.1016/j.chroma.2011.07.029
关键词
Phosphodiesterase type 5 inhibitors; UHPLC; Method validation; Analogues; Counterfeit drugs; Accuracy profiles
Pharmaceutical counterfeiting is a permanently growing problem. Control laboratories are constantly analysing counterfeit medicines. In industrialised countries, one of the main counterfeited class of medicines are erectile dysfunction drugs. This paper describes the development and validation of a fast method to detect and quantify the three authorised phosphodiesterase type 5 inhibitors and five analogues. The method is based on the use of a sub-2 microns polar-embedded column with a gradient using acetonitrile as organic modifier and 10 mM ammonium formate buffer (pH 3.5) as aqueous component of the mobile phase. The separation was achieved in less than 4.5 min. The method has also been compared to the registered HPLC method for the assay of Viagra (R) which was considered as the reference method. The method is also compatible with on-line coupling mass spectrometry and will significantly reduce analysis times and solvent consumption. (C) 2011 Elsevier B.V. All rights reserved.
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