Ds. Rao et al., LC determination and purity evaluation of nefazodone HCl in bulk drug and pharmaceutical formulations, J PHARM B, 26(4), 2001, pp. 629-636
A simple. selective and reproducible reversed-phase liquid chromatography (
LQ method has been developed for the quantitative determination of nefazodo
ne hydrochloride (I) in the presence of its related impurities. namely 5-et
hyl-4-(2-phenoxyethyl)-2H-1,2,4-triazol-3-(4H)one (II), 1-3-chlorophenyl)-4
-(3-chloropropyl) piperazine hydrochloride (III) and 1,1(1)-trimethylene-bi
s[4-(3-chlorophenyl) piperazine] hydrochloride (IV). The separation was ach
ieved using an Inertsil ODS-3V (250 x 4.6 mm(2)) column and a mobile phase
comprising 0.05 M KH2PO4 (pH 3.0), acetonitrile and methanol in the ratio 5
0:40:10 (v/v/v). The method has been completely validated and proven to be
rugged. The limit of detection and limit of quantification for impurities I
I, III and IV were found to be 50, 79 and 91 ng/ml, and 152, 240 and 280 ng
/ml, respectively. The intra- and inter-day assay precision of the method w
as within 1.2% relative standard deviations, The developed method was appli
ed to the pharmaceutical dosage form (Tablet, Serzone-R) and the percentage
recoveries ranged from 99.1 to 100.7. The percentage recovery of impuritie
s ranged from 96.2 to 108.9, The stability studies were performed for nefaz
odone solution placed on laboratory bench and in the refrigerator for 60 da
ys. The method was proved to be stability indicating in solution. (C) 2001
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