Author : Hayam Lotfy
CoAuthors : Amer SM, Zaazaa HE and Mostafa NS
Source : Austin Journal of Analytical and Pharmaceutical Chemistry
Date of Publication : 01/2015
Abstract :
Simple, accurate, sensitive and precise UV spectrophotometric methods
were developed and validated for quantitative determination of binary mixture of
Naproxen sodium (NAP) and Domperidone maleate (DOM) in their bulk powder
and pharmaceutical dosage forms. NAP was determined in presence of DOM
by direct spectrophtometry at λmax 331 nm. Four spectrophotometric methods,
namely; isoabsorptive point (I), ratio subtraction (II), ratio difference (III) and
mean centering (IV) were developed for the spectral resolution of DOM when
present in mixture with NAP without preliminary separation. In method (I), the
isoabsorptive point (Aiso) at 274.7nm was chosen for determination of DOM
while in method (II), DOM was determined at λmax 287 nm after subtraction of
interference exerted by NAP. In method (III), absorption spectra of DOM were
recorded, divided by suitable divisor of NAP then measuring the absorption
difference at 280 and 294 nm to obtain the corresponding concentrations of
DOM. In method (IV), absorption spectra of each drug were recorded, DOM
spectra were divided by suitable divisor of NAP and the obtained ratio spectra
were mean centered. The concentrations of DOM was then determined from the
calibration graphs obtained by measuring amplitudes at 295nm. The developed
methods were validated according to ICH guidelines demonstrating good
accuracy and precision.
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