Development and validation of a stability-indicating RP-HPLC method to separate low levels of dexamethasone and other related compounds from betamethasone.
Betamethasone (BM) is an active pharmaceutical ingredient (API) or an intermediate which is used to manufacture various finished pharmaceutical products. Betamethasone is also used as a starting material to manufacture other APIs that are related to this steroid family. It is quite a challenging task to separate dexamethasone (DM) peak (the alpha epimer) and other structurally related compounds from BM. A stability-indicating reversed-phase high performance liquid chromatography (RP-HPLC) method has been developed which can separate and accurately quantitate low levels of DM and other related compounds from BM and also from each other. This method was successfully validated for the purpose of conducting stability studies of betamethsone in quality control (QC) laboratories. The stability-indicating capability of this method was demonstrated by adequate separation of DM and all the degradation product peaks from BM peak and also from each other in aged stability samples of betamethasone. A gradient mobile phase system consisting of (A) water:acetonitrile (90:10, v/v) and (B) acetonitrile:isopropanol (80:20, v/v) was used with an ACE Phenyl column (10 cm x 4.6 mm, 3 microm particles, 100 A pore size) and an ultraviolet (UV) detection at 240 nm.
Xiong
Yuan
Y
Global Quality Services-Analytical Sciences, Schering-Plough Corporation, 1011 Morris Avenue, Union, NJ 07083 USA.
Xiao
Kang Ping
KP
Rustum
Abu M
AM
D000465:Algorithms; D000893:Anti-Inflammatory Agents / Q000032:analysis*; D001623:Betamethasone / Q000031:analogs & derivatives* / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid; D003907:Dexamethasone / Q000032:analysis*; D004355:Drug Stability; D011786:Quality Control; D015203:Reproducibility of Results; D012996:Solutions
D000893:Anti-Inflammatory Agents; D012996:Solutions; D003907:Dexamethasone; D001623:Betamethasone