Densitometric Determination of Impurities in Pharmaceuticals. Part VIII. Simultaneous Determination of Fluoxetine and (1RS)-3-Methylamino-1-phenylpropan-1-ol, N-methyl-3-phenylpropan-1-amine, and C-1 as Drug Impurities

摘要

A densitometric TLC method has been developed for identification and quantification of fluoxetine and its impurities-(lRS)-3-methyl-amino-1-phenylpropan-l-ol, N-methyl-3-phenylpropan-l-amine,andC-1,the last of which has not previously been analyzed. The compounds were separated on silica gel 60 F_(254) HPTLC plates, with chloroform-methanol-25% ammonia,45+4.5+0.5 (v/v), as mobile phase.UV and visible densitometric scanning were performed at X=260 and 530 nm, respectively, after visualization of the chro-matograms with ninhydrin solution. The method enables good separation of the constituents (R_F= 0.20,0.41,0.52,and 0.67) with sufficiently high detection limit and recovery for the individual constituents.