Impurity profile study of repaglinide.

Abstract:

:Three unknown impurities and a byproduct in repaglinide bulk drug at levels below 0.1% (ranging from 0.05 to 0.1%) were detected by a simple isocratic reversed-phase high performance liquid chromatography (HPLC) method. These impurities were isolated from crude sample of repaglinide using reversed-phase preparative high performance liquid chromatography. Based on the spectroscopic data (IR, NMR and MS) the structures of these impurities (I, II and IV) and byproduct (III) were characterised as 4-carboxymethyl-2-ethoxy-benzoic acid (I), 4-cyclohexylaminocarbamoylmethyl-2-ethoxy-benzoic acid (II), 1-cyclohexyl-3-[3-methyl-1-(2-piperidin-1-yl-phenyl)-butyl]-urea (IV) and 1,3-dicyclohexyl urea (III), respectively. Their synthesis and formation is discussed.

journal_name

J Pharm Biomed Anal

authors

Reddy KV,Babu JM,Mathad VT,Eswaraiah S,Reddy MS,Dubey PK,Vyas K

doi

10.1016/s0731-7085(03)00216-4

subject

Has Abstract

pub_date

2003-07-14 00:00:00

pages

461-7

issue

3

eissn

0731-7085

issn

1873-264X

pii

S0731-7085(03)00216-4

journal_volume

32

pub_type

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