Bulletin of Faculty of Pharmacy, Cairo University (2013) 51, 185191

Cairo University

Bulletin of Faculty of Pharmacy, Cairo University

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ORIGINAL ARTICLE

HPLC-DAD stability indicating determination

of nizatidine in bulk and capsules dosage form
Tarek S. Belal a,*, Mohamed H. Abdel-Hay a, Suzy M. Sabry a,
Ahmed A. Mahgoub b
a
Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, University of Alexandria, Elmessalah,
21521 Alexandria, Egypt
b
Pharco Pharmaceuticals Company, P.O. Box 12 Sidi Gaber, Alexandria, Egypt

Received 25 December 2012; accepted 2 May 2013

Available online 4 June 2013

KEYWORDS
Nizatidine;
HPLC-DAD;
Stability-indicating determination;
Forced degradation;
Capsules dosage form

Abstract This work describes the stability-indicating determination of the H2-receptor antagonist
nizatidine in its bulk and capsules dosage form using high performance liquid chromatography coupled with diode array detector (HPLC-DAD). The developed method involved the use of Thermo
Hypersil BDS-C8 (4.6 250 mm, 5 lm particle size) column and a mobile phase composed of
0.05 M phosphoric acid and acetonitrile (50:50, v/v). The mobile phase was pumped at a ow rate
of 1 mL/min. Quantication of nizatidine was based on measuring its peak area at 320 nm. The
retention time for nizatidine was about 3.61 min. The reliability and analytical performance of
the proposed HPLC procedure were statistically validated with respect to linearity, range, precision,
accuracy, specicity, robustness, detection and quantication limits. Calibration curve of nizatidine
was linear in the range of 550 lg/mL with correlation coefcient >0.9999. The drug was subjected
to forced-degradation conditions of acidic and basic hydrolysis, oxidation, dry heat and UV photolysis where it showed considerable degradation in basic and oxidative conditions. The proposed
method proved to be specic and stability-indicating by resolution of the drug from its forceddegradation products. The validated HPLC method was applied to the analysis of nizatidine in
capsules dosage form where it was quantied with recoveries not less than 98.2%. Assay results
were statistically compared to USP 2011 pharmacopeial method where no signicant difference
was observed between the proposed and reference methods.
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* Corresponding author. Tel.: +20 3 4871317; fax: +20 3 4873273.

E-mail addresses: tbelaleg@yahoo.com, tbelal1972@yahoo.com
(T.S. Belal).
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1. Introduction
Nizatidine (NZ) (Fig. 1) chemically known as N-[2-[[[2[(dimethylamino)methyl]-4-thiazolyl]methyl]thio]ethyl]-N0 -methyl2-nitro-1,1-ethenediamine, is a histamine H2-antagonist. It
inhibits the actions of histamine mediated by H2-receptors
such as gastric acid secretion and pepsin output. It is used
where the inhibition of gastric acid secretion may be benecial,

1110-0931 2013 Production and hosting by Elsevier B.V. on behalf of Faculty of Pharmacy, Cairo University.
Open access under CC BY-NC-ND license. http://dx.doi.org/10.1016/j.bfopcu.2013.05.001

186
H 3C

T.S. Belal et al.

N
CH3

Figure 1

NO2

2. Experimental
2.1. Instrumentation

N
H

N
H

CH3

Chemical structure of nizatidine (NZ).

as in peptic ulcer disease including stress ulceration, gastroesophageal reux, dyspepsia, pathological hypersecretory
states such as the ZollingerEllison syndrome and in patients
at risk of acid aspiration during general anesthesia.1
NZ is an ofcial drug in both the British Pharmacopoeia
(BP 2010)2 and the Unites States Pharmacopeia (USP 2011)3
where HPLC procedures are described for the assay of the
bulk powder and dosage forms (capsules and intravenous infusion). The analytical prole4 of NZ provides a survey for the
reported methods of analysis during the eighties of the last century. Moreover, the quantication of NZ in its pharmaceutical
formulations and/or biological samples was addressed in several reports. Analytical methodology in these reports involved
the use of potentiometric titration with palladium (II) chloride,5 oxidimetric titration with N-bromosuccinimide,6 DC
and differential-pulse polarography,7 cathodic stripping voltammetry on hanging mercury drop electrode8 and several color-producing spectrophotometric methods employing various
reactions and reagents.6,812 Recently, a sensitive uorescence
probe for determination of NZ in tablets and biological uids
was presented.13 Also, the scientic literature showed the use
of separation techniques such as capillary zone electrophoresis
for separation and simultaneous determination of some H2
receptor antagonists including NZ,14,15 HPLC-tandem mass
spectrometry (LCMSMS) for detection of eight anti-ulcer
drugs simultaneously in horse urine16 and several HPLC-UV
detection methods which were directed for NZ determination
in commercial products17 or in human plasma and urine samples.1820
A review of the literature reveals a few number of reported
stability indicating assay methods for NZ. Spectrophotometric
stability indicating assay methods for the determination of intact NZ in the presence of its degradation products were developed.21,22 These methods involved the formation of colored
products between NZ and bromophenol blue21 or 3-methyl2-benzothiazolinone hydrazone (MBTH)22 followed by measuring peak heights of their rst derivative spectra. Stability
indicating determination of NZ in the presence of its oxidative
degradation product (sulfoxide derivative) was carried out
using derivative and derivative ratio spectrophotometry as well
as TLC densitometry.23 Recently, RP-HPLC was adopted for
the stability indicating determination of NZ in the presence of
its impurities and forced degradation products.24 Finally, a
RP-UPLC method was reported for the stability indicating assay of oral liquid pharmaceutical formulation containing NZ,
methylparaben and propylparaben.25
The aim of this work is the development, validation and
application of a simple, rapid, selective and reliable HPLCDAD method for the analysis of NZ in bulk powder and in
capsules dosage form. The method was thoroughly tested for
its specicity and stability-indicating properties by resolution
of the parent drug from its forced hydrolytic, oxidative, dry
heat and photolytic degradation products.

The HPLC-DAD system consisted of Agilent 1200 series (Agilent Technologies, Santa Clara, CA, USA) (quaternary pump,
vacuum degasser and diode array, autosampler and thermostated column compartment) connected to a computer loaded
with Agilent ChemStation software. Columns used in the study
were Thermo Hypersil BDS-C8 (4.6 250 mm, 5 lm particle
size), Thermo Hypersil BDS-C18 (4.6 250 mm, 5 lm particle
size) and Zorbax Eclipse XDBC18 (4.6 150 mm, 5 lm particle size). Filtration was done using cellulose nitrate membrane lters (0.45 lm pore size) (Sartorius Stedim Biotech
GmbH, Goettingen, Germany) with the aid of VALUE
VG215 2-stage vaccum pump (Zhejiang, China).
2.2. Materials and chemicals
Authentic sample of Nizatidine (NZ) was kindly provided by
the Alexandria Company for Pharmaceuticals and Chemical
Industries, Alexandria, Egypt, and was certied to contain
99.5% NZ. Analytical grade of orthophosphoric acid, sodium
hydroxide, hydrochloric acid, 30% hydrogen peroxide and
high purity distilled water were used. HPLC grade acetonitrile
and methanol (LAB-SCAN Analytical Sciences, Poland) were
used. Pharmaceutical formulation assayed in the study was
Ulcfree capsules (EVA Pharma for Pharmaceuticals & Medical Appliances, Giza, Egypt, BN. 905656) labeled to contain
150 mg of NZ per capsule, and it was purchased from the local
market.
2.3. General procedure
The optimal composition of the mobile phase was determined
to be acetonitrile and 0.05 M phosphoric acid (50:50, v/v). The
mobile phase was pumped isocratically at a ow rate of 1 mL/
min. The injection volume was 20 lL. The eluant was monitored by the diode array detector from 190 to 400 nm, and
chromatograms were recorded at 210, 254 and 320 nm. All
determinations were performed at 25 C.
NZ stock standard solution (1000 lg/mL) was prepared in
HPLC-grade methanol. The prepared stock solution was
stored and refrigerated at 4 C. The working solutions were
prepared by the dilution of NZ stock standard solution
with the mobile phase to reach the concentration range of
550 lg/mL. Triplicate 20 lL injections were made for each
concentration and chromatographed under the previously
described LC conditions. The peak areas at 320 nm were
plotted against the corresponding concentrations to construct
the calibration graph.
2.4. Assay of capsules
The contents of 10 Ulcfree capsules were accurately weighed,
mixed, nely powdered and the average weight per capsule was
determined. An accurate weight of the nely powdered sample
equivalent to 50 mg of NZ was extracted into 25 mL methanol
(HPLC grade) with the aid of sonication for 30 min then ltered into a 50 mL-volumetric ask. The residue was washed

HPLC-DAD stability indicating determination of nizatidine in bulk and capsules dosage form
with 2 10 mL portions of methanol and washings were added
to the ltrate. The ltrate was diluted to volume with methanol
to reach a nal concentration of 1000 lg/mL for NZ (stock
sample solution). For the prepared stock sample solution, further dilutions in the mobile phase were made to obtain sample
solutions of nal concentrations within the linearity range of
550 lg/mL, and the general procedure was then followed.
Recovery values were calculated from similarly treated standard solutions. For standard addition assay, sample solutions
were spiked with aliquots of stock standard NZ to obtain total
concentrations within the previously specied range then treated as under general procedure. Recovered concentrations
were calculated by comparing the analyte response with the
increment response attained after the addition of the standard.
2.5. Preparation of forced-degradation solutions
For the acid and base forced degradation solutions, volumes of
1 mL of NZ stock standard solution were transferred into 50mL volumetric asks. Volumes of 2-mL of 1 M HCl or 1 M
NaOH were added and the mixtures were kept at room temperature for 24 h. Similar reaction mixtures were prepared in
test tubes and were placed in a water-bath at 80 C for 2 h
(for the acid degradation solution) and 30 min (for the base
degradation solution). During heating, volume loss was compensated with methanol. After the specied time intervals,
the mixtures in the test tubes were quantitatively transferred
into 50-mL volumetric asks. All solutions were neutralized
with appropriate volumes of 1 M NaOH or 1 M HCl and diluted to volume with mobile phase to reach nal concentrations of 20 lg/mL NZ.
For the oxidative degradation solution, a volume of 1 mL
of NZ stock standard solution was transferred into a 50-mL
volumetric ask. A volume of mL of H2O2 6% (prepared
by dilution of hydrogen peroxide 30% with water) was added
and the mixture was kept at room temperature for 24 h. Another similar reaction mixture was prepared in a test tube
and was placed in a water-bath at 80 C for 30 min. After
the specied time interval, the mixture in the test tube was
quantitatively transferred into a 50-mL volumetric ask, and
then both solutions were diluted to volume with mobile phase
to reach nal concentrations of 20 lg/mL NZ.
For the UV photolytic and dry heat degradations, amounts
of NZ powder (50 mg) were subjected to UV irradiation at
254 nm for 3 h or kept in an oven at 100 C for 24 h. After
the specied time intervals, each powder was dissolved in
methanol, and aliquots of these methanolic stocks were diluted
with the mobile phase to reach nal concentrations of 20 lg/
mL NZ.

187

stationary phase, several reversed phase C8 and C18 columns

were tested. The best resolution of NZ from its degradation
products and best NZ peak shape were attained by using Thermo Hypersil BDS-C8 (4.6 250 mm, 5 lm) column, and hence
it was used in this study. Several mobile phases were tried
using various proportions of different aqueous phases and organic modiers. Decreasing the acetonitrile content in the mobile phase led to longer retention times and excessive peak
tailing. While increasing acetonitrile content yielded a NZ
peak that was very close to the solvent peak, in addition to
insufcient resolution of the parent drug peak from some of
its degradation products peaks. Methanol was tried as an organic modier and different aqueous phases (water, acetate
buffer) were examined. In these trials, chromatograms showed
broad asymmetric NZ peaks and/or increased retention times
and, consequently, fewer theoretical plates for NZ. The best
chromatogram (Fig. 2) was obtained using a mobile phase consisting of acetonitrile and 0.05 M phosphoric acid (50:50, v/v)
pumped isocratically at a ow rate of 1.0 mL/min. The proposed method has the advantage of using such simple mobile
phase where there is no need for the preparation of buffer or
adjustment of pH.
Diode array detection enhances the power of HPLC and is
an elegant option for assessing method specicity by monitoring the recorded spectra during peak elution. Quantication
was achieved using diode array detection based on peak area
measurement. NZ exhibits considerable absorption over the
range of 200350 nm with a prominent maximum at 320 nm,
therefore it was selected for NZ quantication. In addition,
other wavelengths such as 210 and 254 nm were found suitable
for recording chromatograms of the degradation solutions because some of the degradation products did not show enough
absorption at 320 nm. Table 1 assembles the optimized chromatographic conditions for this study. The previously described chromatographic conditions showed well dened NZ
peak at 3.608 0.033 min. Column performance (apparent
efciency) can be expressed by the number of theoretical plates
(N) which equals 4380.
3.2. Stability indicating aspects
Forced degradation experiments were carried out on standard
NZ in order to produce the possible relevant degradation
products and test their chromatographic behavior using the
developed method. Hydrolytic, using strong acidic (1 M
HCl) and strong basic (1 M NaOH) media, oxidative (6%
H2O2), photolytic and dry heat degradation experiments were

3. Results and discussion

3.1. Optimization of chromatographic conditions
A stability-indicating HPLC-DAD method was developed to
provide a simple, rapid and reliable quality control analysis
of NZ in capsules. The most important aspect in LC method
development is the achievement of sufcient resolution with
acceptable peak symmetry in a reasonable analysis time. To
achieve this goal, several experiments were carried out in order
to optimize both the stationary and mobile phases. For the

Figure 2 Typical HPLC chromatogram of a 20-lL injection of

20 lg/mL NZ at 320 nm.

188
Table 1

T.S. Belal et al.

Optimized chromatographic conditions.

Column

Thermo Hypersil reversed phase

BDS-C8 (4.6 250 mm, 5 lm particle
size)

Mobile phase

Isocratic elution of 0.05 M orthophosphoric acid and acetonitrile

(50:50, v/v)
320 nm (for quantication of NZ)
210, 254 and 320 nm (for recording of
degradation chromatograms)
1.0 mL/min
25 C

Wavelength (nm)

Flow rate (mL/min)

Temperature

Figure 4 HPLC chromatogram of 20 lg/mL NZ after exposure

to alkaline degradation with 1 M NaOH/80 C for 30 min.

Figure 3 HPLC chromatogram of 20 lg/mL NZ after exposure

to acid degradation with 1 M HCl/80 C for 2 h.

conducted, and the resulting chromatograms were compared

with that obtained from standard untreated solution of the
drug (Fig. 2).
Hydrolytic and oxidative degradation studies on NZ were
conducted either at room temperature or with the aid of heating. In strong acidic medium, no degradation of NZ was noticed. The drug peak appeared at its specic retention time
with area identical to that of standard of the same concentration, additionally, the chromatograms of NZ after exposure to
forced acidic conditions did not show any extra peaks. Fig. 3
shows the intact NZ peak after heating at 80 C for 2 hrs with
1 M HCl. On the other hand, alkaline degradation with 1 M
NaOH at room temperature caused about 6% reduction in
the peak area of NZ, while about 26% decrease in NZ peak
area was observed after heating at 80 C for 30 min. A wellresolved major degradation peak can be seen in the chromatogram at a retention time of 2.34 min (Rs = 7.69 between NZ
peak and the alkaline degradation peak) (Fig. 4).
Oxidative H2O2 degradation at room temperature revealed
quite an intact NZ peak as indicated from its peak area compared to standard of the same concentration. The situation
was much different upon heating at 80 C for 30 min where
a remaining NZ peak eluted with about 40% of the expected
area, and a degradation product peak appeared at 3.20 min
(Rs = 2.43). The sulfur atom in the side chain of NZ is susceptible to oxidation, accordingly, the oxidative degradation
product is most probably the S-oxide derivative of NZ (nizatidine sulfoxide).23 Fig. 5 illustrates the chromatogram of NZ
after heating with 6% hydrogen peroxide at 80 C for
30 min. No degradation was observed after exposure of NZ
powder to UV photolytic or dry heat forced degradation

Figure 5 HPLC chromatogram of 20 lg/mL NZ after exposure

to oxidative degradation with 6% H2O2/80 C for 30 min.

Figure 6 HPLC chromatogram of 20 lg/mL NZ after exposure

to UV irradiation at 254 nm for 3 h.

conditions. After the specied time intervals, solutions were

prepared from the stressed powder samples. The NZ peak appeared at its specic retention time with area identical to that
of a standard of the same concentration, additionally, no extra
peaks were observed in the chromatograms (Figs 6 and 7).
In all these forced degradation experiments, NZ was successfully separated from all the degradation products as conrmed by the resolution values calculated for each
chromatogram (Rs > 1.5). Also the identity and purity of
NZ were conrmed by the diode array detector (DAD), and
no signs of co-elution from any of the degradation products
were detected.

HPLC-DAD stability indicating determination of nizatidine in bulk and capsules dosage form

189

ratio method and are given in Table 2. Both LOD and LOQ values conrm the sensitivity of the proposed HPLC procedure.
3.3.3. Accuracy and precision

Figure 7 HPLC chromatogram of 20 lg/mL NZ after exposure

to dry heat degradation at 100 C for 24 h.

3.3. Validation of the proposed method

3.3.4. Robustness

3.3.1. Linearity and concentration range

Under the optimal experimental chromatographic conditions,
linear relationship exists between the integrated peak area
and the corresponding concentration of NZ. The performance
data and statistical parameters including linear regression
equation, concentration range, correlation coefcient (r) and
other statistical parameters such as the standard deviation of
the intercept (Sa), the slope (Sb) and standard deviation of
residuals (Sy/x) are listed in Table 2. Regression analysis for
the calibration curve showed good linear relationship over
the concentration range of 550 lg/mL as judged by the correlation coefcient value (r = 0.99993), the RSD% of the slope
which did not exceed 1% and the y-intercept, a, which was less
than 2% of the response for the target value of the analyte.26
3.3.2. Detection and quantication limits
According to the pharmacopeial recommendations3 and the
ICH guidelines on validation of analytical procedures,27 the limit of detection (LOD) is dened as the concentration of the analyte which has a signal-to-noise ratio of 3:1. For the limit of
quantication (LOQ), the ratio considered is 10:1. The LOD
and LOQ values of NZ were calculated using the signal-to-noise
Table 2 Analytical parameters for the determination of NZ
using the proposed HPLC-DAD method.
Parameter

Value

Linearity range (lg/mL)

Intercept (a)
% y-intercepta
(Peak area at 100% target concentration)
Slope (b)
RSD% of slope
Correlation coecient (r)
Sab
Sbc
Sy/xd
LOD (lg/mL)
LOQ (lg/mL)

550
7.61
0.87 (874.6)
44.11
0.61
0.999925
8.17
0.27
10.50
0.31
1.03

yintercept
% y-intercept = peak area at 100%
target concentration  100
Sa: standard deviation of intercept.
c
Sb: standard deviation of slope.
d
Sy/x: standard deviation of residuals (standard error of
estimate).
a

The within-day (intra-day) precision and accuracy for the proposed method were studied at three concentration levels (10,
20 and 40 lg/mL) using three replicate determinations for each
concentration within one day. Similarly, the between-day (inter-day) precision and accuracy were tested by analyzing the
same three concentrations using three replicate determinations
repeated for three days. Recovered concentrations were calculated using the corresponding regression equation and they
were satisfactory. The percentage relative standard deviation
(RSD%) and percentage relative error (Er%) were less than
1.5% proving the high repeatability and accuracy of the developed method for the estimation of NZ in bulk form (Table 3).

The robustness of an analytical procedure is a measure of its capability to remain unaffected by small but deliberate variations in
method parameters and provides an indication of its reliability during normal usage.3,27 Robustness was examined by making small
changes in acetonitrile content in the mobile phase (2%), ow
rate (0.05 mL/min), column temperature (2 C) or working
wavelength (2 nm) and examining the results. These variations
did not have any signicant effect on the measured response (peak
area) or retention time of NZ. Table 4 shows the effects of the studied variations on the retention time and peak area of NZ. Additionally, these minor experimental changes did not affect the separation
of NZ from its degradation products.
3.3.5. Specicity and selectivity
Specicity of the method was assessed by comparing the chromatograms obtained from standard solution with the chromatograms obtained from capsules sample solution. As the
retention time of the standard drug and the retention time of
the drug in capsule test solution were the same, so the method
was specic. On the other hand, the use of photodiode array
detector allowed conrming the selectivity of the method by
comparison with the reference drug spectrum, hence the method proved to be selective in separation of the investigated drug.
Selectivity was also demonstrated by the separation of NZ
from forced degradation products and formulation additives.
3.3.6. Stability of solutions
The stability of the analytes working solutions in the mobile
phase was examined, and no chromatographic changes were
observed within 5 h at room temperature. Also, the stock solutions prepared in HPLC-grade methanol were stable for at
least one week when stored and refrigerated at 4 C.
3.4. Assay of capsules
The developed stability-indicating HPLC procedure was applied to the assay of NZ in the pharmaceutical formulation
available in the local market (Ulcfree capsules). The active
ingredient eluted at its specic retention time, and no interfering
peaks were observed in the chromatograms of NZ capsules. The
diode-array detection enables peak purity verication where no
signs of co-elution from any of the inactive components were

190

T.S. Belal et al.

Table 3

Accuracy and precision for the analysis of NZ in bulk form using the proposed HPLC-DAD method.

Within-day

Between-day

a
b
c

Table 4

Nominal value
(lg/mL)

Found SDa (lg/mL)

RSD(%)b

Er (%)c

10
20
40
10
20
40

9.93 0.07
19.74 0.16
40.01 0.23
9.96 0.11
19.98 0.27
40.19 0.34

0.71
0.81
0.58
1.10
1.35
0.85

0.70
1.30
0.03
0.40
0.10
0.48

Mean standard deviation for three determinations.

% Relative standard deviation.
% Relative error.

Robustness of the proposed HPLC-DAD method.

Chromatographic
parameter

NZ peak area

NZ retention
time (min)

Acetonitrile percentage in the mobile phase

48
843
50
831
52
820
RSD%
1.38

3.81
3.74
3.70
1.49

Flow rate (mL/min)

0.95
1.00
1.05
RSD%

868
831
803
3.91

3.95
3.74
3.58
4.94

Column temperature (C)

23
25
27
RSD%

835
831
823
0.74

3.76
3.74
3.71
0.67

Working wavelength (nm)

318
320
322
RSD%

817
831
828
0.89

detected. Recoveries were calculated using both external standard and standard addition methods. The assay results revealed
satisfactory accuracy and precision as indicated from % recovery, SD and RSD% values (Table 5).
Furthermore, the USP reference HPLC method3 was applied for the estimation of NZ in its commercial product.
The pharmacopeial method is based on the analysis of NZ

using a RP-C18 column (4.6 mm 15 cm, 5 lm particle size),

the mobile phase consisted of methanol and 0.1 M ammonium
acetate adjusted to pH 7.5 with acetic acid (24:76, v/v) and UV
detection at 230 nm. According to these conditions, the internal standard (phenol) and NZ eluted at retention times 8.74
and 11.17 min respectively. Recovery data obtained from the
proposed HPLC method were statistically compared with
those of the reference method using the Students t- and the
variance ratio F-tests. In both tests, the calculated values did
not exceed the theoretical ones at the 95% condence level
which indicated that there were no signicant differences between the recoveries obtained from the developed method
and those of the reference method (Table 5). It is evident from
these results that the proposed method is applicable to the assay of NZ capsules with satisfactory level of selectivity, accuracy and precision.
4. Conclusion
A simple, rapid and selective HPLC-DAD procedure was
developed for the assay of NZ in bulk form and in capsules.
The analyte was quantied using a RP-C8 column in a short
run time; consequently, the developed method can be considered cost and time-effective. The proposed method is sensitive
enough to determine a concentration down to 5 lg/mL NZ.
Moreover, the method was extended to study the degradation
behavior of NZ under different forced degradation conditions.
Few reports were published concerning the forced degradation
of NZ and/or its stability indicating determination. Obviously,
the described HPLC method offers selectivity advantage
over the spectrophotometric non-separation methods describing the stability indicating estimation of NZ.2123 Also, the
proposed HPLC method is more reliable than the stability

Table 5 Analysis of NZ in its pharmaceutical preparation (Ulcfree capsules) using the proposed HPLCDAD method and the reference method.
Method results
a

%Recovery SD
RSD%b
t
F

External standard

Reference method3

Standard addition

99.24 0.552
0.556
1.78
1.85

99.78 0.406
0.407

99.08 0.791
0.798

Theoretical values for t and F at P = 0.05 are 2.31 and 6.39, respectively.
a
Mean standard deviation for ve determinations.
b
% Relative standard deviation.

HPLC-DAD stability indicating determination of nizatidine in bulk and capsules dosage form
indicating TLC-densitometry procedure which was only applied for the assay of NZ in the presence of its oxidative degradation product.23 The method holds a challenge and is
advantageously compared with the other reported liquid chromatographic methods,2,3,18,25,26 briey mentioning the following points: short run time (5 min), simple since no internal
standard is required and the mobile phase is pumped isocratically while multi-step gradient elutions are applied in other
procedures24,25 and nally the developed method made use
of the diode array detector as a tool for peak identity and purity conrmation; however, it can be adapted to conventional
HPLC with UV detection which is the most popular in quality
control laboratories.
5. Conict of interest
None.
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