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Sci. Pharm. 2012, 80(3), 605-618; doi:10.3797/scipharm.1204-13

Identification and Characterization of Potential Impurities in Raloxifene Hydrochloride

1
Chemical Research & Development, NPNC Division, Orchid Chemicals and Pharmaceutical Limited, Sozhanganallur, Chennai 600 119, Tamilnadu, India
2
Analytical Research & Development, Orchid Chemicals and Pharmaceutical Limited, Sozhanganallur, Chennai 600 119, Tamilnadu, India
*
Author to whom correspondence should be addressed.
Received: 16 April 2012 / Accepted: 22 May 2012 / Published: 22 May 2012
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Abstract

During the synthesis of the bulk drug Raloxifene hydrochloride, eight impurities were observed, four of which were found to be new. All of the impurities were detected using the gradient high performance liquid chromatographic (HPLC) method, whose area percentages ranged from 0.05 to 0.1%. LCMS was performed to identify the mass number of these impurities, and a systematic study was carried out to characterize them. These impurities were synthesized and characterized by spectral data, subjected to co-injection in HPLC, and were found to be matching with the impurities present in the sample. Based on their spectral data (IR, NMR, and Mass), these impurities were characterized as Raloxifene-N-Oxide [Impurity: 1]; EP impurity A [Impurity: 2]; EP impurity B [Impurity: 3]; Raloxifene Dimer [Impurity: 4]; HABT (6-Acetoxy-2-[4-hydroxy-phenyl]-1-benzothiophene or 6-Hydroxy-2-[4-acetoxyphenyl]-1-benzothiophene) [Impurity: 5]; PEBE (Methyl[4-[2-(piperidin-1-yl)ethoxy]]benzoate) [Impurity: 6]; HHBA (1-[6-hydroxy-2-(4-hydroxyphenyl)-1-benzothiophen-3-yl]ethanone) [Im-purity: 7]; 7-MARLF (7-Acetyl-[6-hydroxy-2-(4-hydroxyphenyl)-1-benzothiophen-3-yl][4-[2-(piperidin-1-yl)ethoxy]phenyl methanone) [Impurity: 8]; of which impurities 5–8 are reported for the first time.
Keywords: Raloxifene; Impurities; Isolation; Synthesis; Preparative high performance liquid chromatography; Characterization; Evista Raloxifene; Impurities; Isolation; Synthesis; Preparative high performance liquid chromatography; Characterization; Evista
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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MDPI and ACS Style

BUCHI REDDY, R.; VENKATESHWAR GOUD, T.; NAGAMANI, N.; PAVAN KUMAR, N.; ALAGUDURAI, A.; MURUGAN, R.; PARTHASARATHY, K.; KARTHIKEYAN, V.; BALAJI, P. Identification and Characterization of Potential Impurities in Raloxifene Hydrochloride. Sci. Pharm. 2012, 80, 605-618.

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