Determination of naphazoline HCl, pheniramine maleate and their official impurities in eye drops and biological fluid rabbit aqueous humor by a validated LC-DAD method.

ABSTRACT: A simple RP-HPLC-DAD method was developed and validated, as per the ICH guidelines, for simultaneous determination of naphazoline HCl (NPZ) & pheniramine maleate (PHN) along with three of their official impurities. Chromatographic separation was performed on a hypersil ODS column (5 mm, 250-4.6 mm i.d.) with isocratic elution using phosphate buffer pH 6.0: acetonitrile (70 : 30, v/v) as mobile phase, at a flow rate of 1.0 mL min^-1 and UV detection at 260.0 nm. The developed method was found to be linear over the concentration ranges of 5.00-45.00 μg mL^-1 for NPZ and NPZ impurity B and 10.00-110.00 μg mL^-1, 10-70 μg mL^-1 and 10-120 μg mL^-1 for PHN, and PHN impurity A and B, respectively, with correlation coefficient values <0.999 for th

SUBMITTER: Kelani KM 

PROVIDER: S-EPMC8694919 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature