چکیده (انگلیسی):

Four accurate and sensitive methods were developed and validated for determination of
naphazoline hydrochloride (NAP) and chlorpheniramine maleate (CLO) in the presence of naphazoline
hydrochloride alkaline degradation product (NAP Deg). The first method is a spectrophotometric
one , where NAP was determined by the fourth derivative (D4) spectrophotometric method by measuring
the peak amplitude at 302 nm, while CLO was determined by the second derivative of the ratio
spectra (DD2) spectrophotometric method at 276.4 nm. The second method is a chemometric-assisted
spectrophotometric method in which partial least squares (PLS-1) and partial component regression
(PCR) were used for the determination of NAP, CLO and NAP Deg using the information contained
in their absorption spectra of ternary mixture. The third method is a TLC-densitometric one where
NAP,CLOandNAP Deg were separated usingHPTLCsilica gel F254 plates using ethyl acetate:methanol:
ammonia: (8:2:0.5, by volume) as the developing system followed by densitometric measurement
at 245 nm. The fourth method is HPLC method whereNAP, CLOand NAPDeg were separated using
ODS C18 column and a mobile phase consisting of 0.1M KH2PO4 (pH=7):methanol (55:45 v/v)
delivered at 1.5 mL min1 followed by UV detection at 265 nm. The proposed methods have been successfully
applied to the analysis ofNAP and CLOin pharmaceutical formulations without interference
from the dosage form additives and the results were statistically compared with a reported method.