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Spectrochimica Acta Part A 68 (2007) 250256

Validated spectrophotometric methods for the estimation of


moxifloxacin in bulk and pharmaceutical formulations
Sanjay K. Motwani , Shruti Chopra 1 , Farhan J. Ahmad 1 , Roop K. Khar 1
Department of Pharmaceutics, Faculty of Pharmacy, Jamia Hamdard, Hamdard Nagar, New Delhi 110062, India
Received 2 July 2006; received in revised form 18 October 2006; accepted 17 November 2006

Abstract
New, simple, cost effective, accurate and reproducible UV-spectrophotometric methods were developed and validated for the estimation
of moxifloxacin in bulk and pharmaceutical formulations. Moxifloxacin was estimated at 296 nm in 0.1N hydrochloric acid (pH 1.2) and at
289 nm in phosphate buffer (pH 7.4). Beers law was obeyed in the concentration range of 112 g ml1 (r2 = 0.9999) in hydrochloric acid and
114 g ml1 (r2 = 0.9998) in the phosphate buffer medium. The apparent molar absorptivity and Sandells sensitivity coefficient were found to
be 4.63 104 l mol1 cm1 and 9.5 ng cm2 /0.001 A in hydrochloric acid; and 4.08 104 l mol1 cm1 and 10.8 ng cm2 /0.001 A in phosphate
buffer media, respectively indicating the high sensitivity of the proposed methods. These methods were tested and validated for various parameters
according to ICH guidelines. The detection and quantitation limits were found to be 0.0402, 0.1217 g ml1 in hydrochloric acid and 0.0384,
0.1163 g ml1 in phosphate buffer medium, respectively. The proposed methods were successfully applied for the determination of moxifloxacin
in pharmaceutical formulations (tablets, i.v. infusions, eye drops and polymeric nanoparticles). The results demonstrated that the procedure is
accurate, precise and reproducible (relative standard deviation <2%), while being simple, cheap and less time consuming and hence can be suitably
applied for the estimation of moxifloxacin in different dosage forms and dissolution studies.
2006 Elsevier B.V. All rights reserved.
Keywords: Moxifloxacin; Spectrophotometry; Method validation; Pharmaceutical dosage form

1. Introduction
Moxifloxacin (Fig. 1) is a fourth generation 8-methoxy fluoroquinolone derivative [1-cyclopropyl-6-fluoro-1,4-dihydro-8methoxy-7-{(4aS,7aSocta-hydro-6H-pyrrolol (3,4b) pyridin6-yl)}-4-oxo-3-quinoline carboxylic acid, monohydrochloride]
with extended-spectrum and improved activity against Grampositive bacteria (including staphylococci, streptococci, enterococci), anaerobes and atypical bacteria [1,2]. The bactericidal
activity of moxifloxacin is mediated by the inhibition of
DNA gyrase (topoisomerase II) and topoisomerase IV, essential
enzymes involved in bacterial DNA replication, transcription, repair and recombination [3]. Moxifloxacin is prescribed
for the bacterial infections of the respiratory tract including
sinusitis, community acquired pneumonia and acute exacerba

Corresponding author at: Department of Pharmaceutics, Faculty of Pharmacy, Jamia Hamdard, Hamdard Nagar, New Delhi 110062, India.
Tel.: +91 11 26059688; fax: +91 11 26059663.
E-mail address: sanjay bcp@rediffmail.com (S.K. Motwani).
1 Tel.: +91 11 26059688; fax: +91 11 26059663.
1386-1425/$ see front matter 2006 Elsevier B.V. All rights reserved.
doi:10.1016/j.saa.2006.11.023

tions of chronic bronchitis [4]. Due to clinical advantages of


moxifloxacin, there has been increase in number of moxifloxacin
formulations in market in recent past.
For routine analysis a simple, rapid and cost effective analytical method is preferred. A survey of literature has not revealed
any simple UV-spectrophotometric method for estimation of
moxifloxacin in bulk drug, formulations and dissolution media
of oral and ophthalmic formulations. Various methods have been
reported in literature for the analysis of moxifloxacin including high-performance liquid chromatography (HPLC) with
fluorescence [58] or UV detection [810]. Voltametry [11],
capillary electrophoresis with laser-induced fluorescence [12]
and reverse-phase HPLC/fluorescence [13] are also reported
for determination of moxifloxacin from human body fluids.
But, chromatographic techniques are time consuming, costly
and require expertise. Development of simple and accurate
UV-spectrophotometric methods can provide a very useful alternative for routine analysis of bulk drug, formulations and
dissolution samples.
The objective of the present study was to develop simple,
precise, accurate and validated, economic analytical methods

S.K. Motwani et al. / Spectrochimica Acta Part A 68 (2007) 250256

Fig. 1. Chemical structure of moxifloxacin.

for the estimation of moxifloxacin in bulk, pharmaceutical formulations, and in vitro dissolution studies of oral and ophthalmic
formulations. Two analytical methods have been developed in
different media for estimation of moxifloxacin. Media used were
0.1N hydrochloric acid (HCl) (pH 1.2) and phosphate buffer
(pH 7.4). Moxifloxacin showed absorption maxima at 296 nm
in 0.1N hydrochloric acid (pH 1.2) and at 289 nm in phosphate
buffer (pH 7.4). The developed analytical methods were validated as per ICH guidelines and USP requirements [14,15].
Statistical tests were performed on validation data [16,17].

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tablets contain excipients like iron oxide red, polyethylene


glycol, hydroxypropylmethyl cellulose (HPMC) and titanium
oxide. Moxicip eye drops contain excipients like boric acid.
Moxifloxacin IV infusion contains mannitol and sodium chloride as tonicity adjusting agents. Moxifloxacin polymeric
nanoparticles contains poly (butylcyanoacrylate) polymer and
0.5% Pluronic F68 in aqueous vehicle. All other chemicals and
reagents used were of analytical grade.
2.2. Instruments
A double-beam Shimadzu 1601 UVvis spectrophotometer,
connected to computer and loaded with UV-Probe software was
used. For intermediate precision study, a different Shimadzu
1601 UVvis spectrophotometer connected to computer with
UV-PC software was used. Both the instruments have an automatic wavelength accuracy of 0.1 nm and matched quartz cells
of 10 mm (1.0 cm) cell path length.
2.3. Analytical method development

2. Experimental procedures
2.1. Material and reagents
Moxifloxacin hydrochloride was obtained as gift samples
from Ranbaxy Labs. Ltd. Formulations containing moxifloxacin: Moxif-400 tablets, labelled to contain 400 mg of
moxifloxacin per tablet (Torrent Pharmaceuticals Ltd., India),
Moxif IV Infusion, labelled to contain 400 mg/100 ml of moxifloxacin (Torrent Pharmaceuticals Ltd., India), Moxicip IV Infusion, labelled to contain 400 mg/250 ml of moxifloxacin (Cipla
Ltd., India) and Moxicip 0.5% w/v eye drops (Cipla Ltd.,
India). Moxifloxacin polymeric nanoparticles were prepared
in the laboratory and contain moxifloxacin 2.79 mg/100 mg
of nanoparticles. Apart from common excipients, Moxif-400

Different media were investigated to develop a suitable UVspectrophotometric method for the analysis of moxifloxacin in
formulations. For selection of media the criteria employed were
sensitivity of the method, ease of sample preparation, solubility
of the drug, cost of solvents, applicability and robustness of the
method to various purposes. Absorbance of moxifloxacin in the
selected medium at respective wavelength was determined and
apparent molar absorptivity and Sandells sensitivity coefficients
were calculated according to the standard formulae (Table 1).
2.4. Procedure for calibration curve
Two different stock solutions of 100 g ml1 of moxifloxacin were prepared in 0.1N hydrochloric acid (HCl) (pH

Table 1
Optical characteristics, statistical data of the regression equations and validation parameters for moxifloxacin (n = 9)
Parameter

0.1N HCl

Phosphate buffer, pH 7.4

Optical characteristics
Apparent molar absorptivity (l mol1 cm1 )
Sandells sensitivity (ng cm2 /0.001 A)

4.63 104
9.5

4.08 104
10.8

Regression analysis
Slope (S.E.a )
95% confidence limits of slope
Intercept (S.E.a )
95% confidence limits of intercept
Regression coefficient (r2 )
Calculated F-value (critical F-value)b

0.1060 (1.12 104 )


0.1058; 0.1063
0.0025 (4.30 104 )
0.0035; 0.0015
0.9999
1.649 (2.244)

0.0925 (8.73 105 )


0.0923; 0.0927
0.0029 (3.59 104 )
0.0020; 0.0037
0.9998
1.120 (2.244)

Validation parameters
Specificity and selectivitytcal (tcrit )c
Linearity (g ml1 )
Limit of detection (LOD) (g ml1 )
Limit of quantification (LOQ) (g ml1 )
Robustness (mean %recovery S.D.)

1.29 (2.31)
112
0.0402
0.1217
101.03 1.29

1.10 (2.31)
114
0.0384
0.1163
100.51 0.97

a
b
c

Standard error of mean.


Theoretical value of F is based on one-way ANOVA test at P = 0.05 level of significance.
tcal is calculated value and tcrit is theoretical value (at eight degrees of freedom) based on paired t-test at P = 0.05 level of significance.

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Table 2
Accuracy and method precision data for the developed method (n = 9)
Level

Predicted concentration (g ml1 )a


Range

0.1N hydrochloric acid


LC (2 g ml1 )
IC (5 g ml1 )
HC (10 g ml1 )
Phosphate buffer, pH 7.4
LC (2 g ml1 )
IC (8 g ml1 )
HC (13 g ml1 )
a
b

Mean %recovery (S.D.)

Accuracyb (%)

Mean (S.D.)

% R.S.D.

1.982.02
4.975.03
9.9510.07

2.005 0.013
4.996 0.018
10.007 0.037

0.66
0.35
0.37

100.25 0.658
99.92 0.353
100.07 0.366

0.25
0.08
0.07

1.982.01
7.998.11
12.9513.05

1.996 0.011
8.070 0.040
12.995 0.039

0.55
0.49
0.30

99.82 0.544
100.87 0.498
99.96 0.298

0.18
0.87
0.04

Predicted concentration of moxifloxacin was calculated by linear regression equation.


Accuracy is given in %relative error [=100 (predicted concentration nominal concentration)/nominal concentration].

1.2) and phosphate buffer (PBS) (pH 7.4) by dissolving 5 mg


of moxifloxacin in 50 ml of each media. For preparation of
different concentrations, aliquots of stock solutions were
transferred into a series of 10 ml standard volumetric flasks and
volumes were made with the respective media. Five different
concentrations were prepared in the range of 112 g ml1
of moxifloxacin in HCl. In a similar way, five different
concentrations were prepared in the range of 114 g ml1
of moxifloxacin in the phosphate buffer for standard curve.
Moxifloxacin was estimated at 296 and 289 nm in HCl and
phosphate buffer medium, respectively.
2.5. Sample preparation
Moxifloxacin tablets were powdered and extracted with two
media viz. 0.1N HCl and PBS (pH 7.4) separately. The solutions
were then filtered and suitably diluted to get final concentration
of 5 g ml1 . Eyedrops and i.v. infusions were suitably diluted
to final concentration of 4 g ml1 . Moxifloxacin nanoparticles
were first extracted with acetone and then suitably diluted to get
final concentration of 5.50 g ml1 .
2.6. Analytical method validation
2.6.1. Specificity and selectivity
Moxifloxacin solutions (5 g ml1 ) were prepared in both
the selected media along with and without common excipients
(lactose, microcrystalline cellulose, magnesium stearate, talc,
HPMC, iron oxide red, titanium dioxide, polybutyl (cyanoacrylate) polymer, Pluronic F68, boric acid, mannitol and sodium
chloride) separately. All the solutions were scanned from 450 to

200 nm at a speed of 400 nm min1 and checked for change in


the absorbance at respective wavelengths. In a separate study,
drug concentration of 5 g ml1 was prepared independently
from pure drug stock solution in selected media and analysed
(n = 9). Paired t-test at 95% level of significance was performed
to compare the means of absorbance (Table 1).
2.6.2. Accuracy
To determine the accuracy of the proposed methods, different levels of drug concentrationslower concentration (LC),
intermediate concentration (IC) and higher concentration (HC)
(in both media) were prepared from independent stock solutions
and analyzed (n = 9). Accuracy was assessed as the percentage
relative error and mean %recovery (Table 2). To provide an additional support to the accuracy of the developed assay method,
standard addition method was employed, which involved the
addition of different concentrations of pure drug (1, 2, and
5 g ml1 in HCl medium; 2, 6, and 8 g ml1 in the phosphate
buffer medium) to a known pre-analyzed formulation sample
and the total concentration was determined using the proposed
methods (n = 9) [18]. The %recovery of the added pure drug
was calculated as, %recovery = [(Ct Cs )/Ca ] 100, where Ct
is the total drug concentration measured after standard addition; Cs , drug concentration in the formulation sample; Ca , drug
concentration added to formulation (Table 3).
2.6.3. Precision
Repeatability was determined by using different levels
of drug concentrations (same concentration levels taken in
accuracy study), prepared from independent stock solutions

Table 3
Standard addition method for accuracy (n = 9)
Method

Drug in formulation
(g ml1 )

Pure drug added


(g ml1 )

Total drug found


(g ml1 ) (S.D.)

0.1N hydrochloric acid

5.40
5.40
5.40
5.40
5.40
5.40

1
2
5
2
6
8

6.39
7.44
10.41
7.39
11.50
13.42

Phosphate buffer, pH 7.4

0.032
0.045
0.075
0.042
0.061
0.085

% analytical recovery (S.D.)


99.87
100.50
100.12
99.84
100.89
100.15

0.494
0.612
0.719
0.563
0.539
0.634

S.K. Motwani et al. / Spectrochimica Acta Part A 68 (2007) 250256

253

Table 4
System precision study (n = 9)
Concentration (g ml1 )

Intra-day repeatability %R.S.D. (n = 9)

Inter-day repeatability
%R.S.D. (n = 27)

Intra-instrument repeatability
%R.S.D. (n = 6)

Day 1

Day 2

Day 3

0.1N HCl
2
5
11

0.817 (1.279)
0.734 (0.655)
0.419 (0.813)

1.056 (0.993)
0.451 (0.689)
0.968 (0.727)

0.748 (1.003)
1.031 (0.965)
0.956 (1.083)

0.873 (0.819)
0.739 (0.844)
0.781 (0.329)

1.233 (1.107)
0.887 (0.654)
0.645 (0.773)

Phosphate buffer, pH 7.4


4
8
13

1.245 (0.971)
0.338 (0.409)
0.633 (0.576)

1.387 (0.995)
0.906 (1.372)
1.062 (1.118)

0.763 (0.538)
1.353 (0.984)
1.320 (1.220)

1.131 (0.911)
0.866 (0.983)
1.005 (1.237)

1.719 (1.281)
1.222 (0.963)
0.663 (0.572)

Values in parenthesis shows the values of %R.S.D. for real samples of moxifloxacin eye drop (0.5% w/v).

and analyzed (n = 9) (Table 2). Inter-day, intra-day and interinstrument variation were studied to determine intermediate
precision of the proposed analytical methods. Different levels of drug concentrations in triplicates were prepared three
different times in a day and studied for intra-day variation.
Same procedure was followed for three different days to study
inter-day variation (n = 27). One set of different levels of the
concentrations was re-analyzed using Shimadzu 1601 UVvis
spectrophotometer connected to computer with UV-PC software, by proposed methods to study inter-instrument variation
(n = 3). The percent relative standard deviation (% R.S.D.) of
the predicted concentrations from the regression equation was
taken as precision (Table 4). Precision studies were also carried out using the real samples of moxifloxacin eye drops (0.5%
w/v) in a similar way to standard solution to prove the useful of
method.
2.6.4. Linearity
To establish linearity of the proposed methods, nine separate series of solutions of moxifloxacin (112 g ml1 in
0.1N hydrochloric acid and 114 g ml1 in phosphate buffer
medium) were prepared from the stock solutions and analyzed.
Least square regression analysis was done for the obtained data.
One-way ANOVA test was performed based on the absorbance
values, observed for each pure drug concentration during the
replicate measurement of the standard solutions (Table 1).
2.6.5. Limit of detection (LOD) and limit of quantitation
(LOQ)
The LOD and LOQ of moxifloxacin by the proposed methods
were determined using calibration standards. LOD and LOQ
were calculated as 3.3 /S and 10 /S, respectively, where S is
the slope of the calibration curve and is the standard deviation
of y-intercept of regression equation (n = 9) [14] (Table 1).
2.6.6. Robustness
Robustness of the proposed method was determined by (a)
changing pH of the media by 0.1 units and (b) stability of the
moxifloxacin in both the selected media at room temperature for
24 h. Three different concentrations (LC, IC and HC) were prepared in both the media with different pH and mean %recovery
was determined (Table 1).

2.7. Estimation from formulations


2.7.1. Tablets
Twenty tablets were weighed and pulverized. Amount of
the powder equivalent to 10 mg of moxifloxacin was taken and
extracted with both media separately for 30 min. These solutions
were diluted suitably to prepare a 100 g ml1 concentration in
respective media. Finally solutions were filtered through Whatman filter paper number 40 and the filtrate was suitably diluted
to prepare a 5 g ml1 concentration in both the media separately and the samples were analysed using proposed analytical
methods (Table 5).
2.7.2. Infusion
Aliquot of moxifloxacin infusion equivalent to 4 mg of drug
was taken and diluted with both the media separately to get
a 4 g ml1 concentration in both the media separately and
the samples were analysed using proposed analytical methods
(Table 5).
2.7.3. Eye drops
Aliquot of moxifloxacin eye drop solution equivalent to
5.50 mg of moxifloxacin was taken and suitably diluted with
both the media separately to get a 4 g ml1 concentration and
the samples were analysed using proposed analytical methods
(Table 5).
2.7.4. Moxifloxacin polymeric nanoparticles
Moxifloxacin polymeric nanoparticles equivalent to 5.50 mg
of moxifloxacin was taken and extracted with acetone. It was
then suitably diluted with both the media separately to get
a 5.50 g ml1 concentration and the samples were analysed
using proposed analytical methods (Table 5).
Nine replicates were prepared in all the cases. The results
obtained by the two methods were compared statistically by
applying Students t-test and F-test.
3. Results and discussion
For media optimization various aqueous media like 0.1N
HCl, acetate buffers (pH 3.65.8), phosphate buffers (pH
5.810.2) and 0.1N sodium hydroxide were investigated. Almost

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Table 5
Application of spectrophotometric method to the determination of moxifloxacin from pharmaceutical dosage forms (n = 9)
Commercial formulations

0.1N hydrochloric acid


Amount

foundb

Phosphate buffer, pH 7.4


% assay

Amount foundb

% assay

Moxif400 tablets (400 mg)


Mean S.D. (mg)
ta
Fa

404.23 1.69
1.75 (2.31)
0.51 (2.36)

101.06 0.42

403.36 2.25

100.84 0.56

Moxif IV infusion (400 mg/100 ml)


Mean S.D. (mg/100 ml)
ta
Fa

401.73 2.54
1.41 (2.31)
0.58 (2.36)

100.43 0.64

403.23 2.96

100.81 0.74

Moxicip IV infusion (400 mg/250 ml)


Mean S.D. (mg/250 ml)
ta
Fa

398.79 2.44
1.21 (2.31)
1.79 (2.36)

99.70 0.61

401.68 3.08

100.42 0.77

Eye drop (0.5% w/v or 5 mg ml1 )


Mean S.D. (mg ml1 )
ta
Fa

5.02 0.02
1.23 (2.31)
1.06 (2.36)

100.37 0.38

5.03 0.02

100.61 0.39

Moxifloxacin nanoparticlesc (2.79 mg/100 mg)


Mean S.D. (mg/100 mg)
ta
Fa

2.81 0.02
1.74 (2.31)
0.49 (2.35)

100.55 0.53

2.82 0.02

100.71 0.63

a
b
c

The values in parenthesis are the tabulated values of t and F at P = 0.05.


Amount found is represented as average S.D.
Formulation was prepared in the laboratory.

pH-independent UV absorption spectra of moxifloxacin were


observed for the determination of moxifloxacin in the proposed
analytical media (Fig. 2). Addition of varying amounts of the
methanol to various aqueous media did not improve the sensitivity of the methods and the final decision of using 0.1N HCl
and phosphate buffer (pH 7.4) as a media was based on the criteria like; sensitivity of the method, cost of solvents, ease of
preparation and applicability of the method to dissolution samples. The spectra of moxifloxacin in 0.1N HCl and the phosphate
buffer medium are shown in Fig. 2. The max of moxifloxacin
in 0.1N HCl and phosphate buffer medium were found to be

296 and 289 nm, respectively. Overlain absorption spectra of


moxifloxacin at 0 and 24 h time intervals were recorded in both
the media (Fig. 3). Apparent molar absorptivity of the drug
was found to be 4.63 104 l mol1 cm1 in hydrochloric acid
and 4.08 104 l mol1 cm1 in the phosphate buffer medium,
respectively.
Sandells index represents the number of micrograms or
nanograms of the determinant per millilitre of a solution having
an absorbance of 0.001 for the cell path length of 1 cm and is a

Fig. 2. UV-absorption spectra of 5 g ml1 concentration of moxifloxacin (bulk


form and formulation) in 0.1N HCl and phosphate buffer (pH 7.4).

Fig. 3. UV-absorption spectra of 10 g ml1 concentration of moxifloxacin in


0.1N HCl and phosphate buffer (pH 7.4) at 0 and 24 h time interval.

S.K. Motwani et al. / Spectrochimica Acta Part A 68 (2007) 250256

suitable parameter for expressing and comparing the sensitivities


of developed UV-spectrophotometric methods [19]. Sandells
sensitivity coefficient of moxifloxacin was found to be 9.5 and
10.8 ng cm2 /0.001 A in 0.1N HCl and phosphate buffer media,
respectively (Table 1).
3.1. Calibration curve
In 0.1N HCl, the linear regression equation obtained
was: absorbance at 296 nm = [0.1060 concentration in
g ml1 ] 0.0025; with a regression coefficient of 0.9999.
In phosphate buffer media, the linear regression equation
obtained was: absorbance at 289 nm = [0.0925 concentration
in g ml1 ] + 0.0029; with a regression coefficient of 0.9999.
3.2. Analytical validation
3.2.1. Specificity and selectivity
The UV-spectrum of moxifloxacin was not changed in the
presence of common excipients used in the formulation of
moxifloxacin tablets, eye drops and IV infusions, in both the
selected media. Absorption spectrum of pure drug sample was
matching with the formulation samples in both the selected
media (Fig. 2). The calculated t-values were found to be less than
that of the tabulated t-values, indicating that statistically there
was no significant difference between the mean absorbance of
solutions prepared from pure drug sample and the formulation
samples (Table 1). Therefore proposed analytical methods are
specific and selective for the drug.
3.2.2. Accuracy
Accuracy ranged from 0.08 to 0.39, and 0.18 to 0.87 in
0.1N HCl and phosphate buffer media, respectively (Table 2).
The excellent mean %recovery values, close to 100%, and their
low standard deviation values (S.D. < 1.0) represent high accuracy of the analytical methods. The validity and reliability of
the proposed methods was further assessed by recovery studies by standard addition method (Table 3). In 0.1N HCl, the
mean %recoveries (%R.S.D.) for lower, intermediate and higher
concentrations were found to be 100.25 (0.658), 99.92 (0.353)
and 100.07 (0.366), respectively. In phosphate buffer, the mean
%recoveries (% R.S.D.) for lower, intermediate and higher concentrations were found to be 99.82 (0.544), 100.87 (0.498) and
99.96 (0.298), respectively. Slopes for the standard addition samples and calibration curve in 0.1N HCl were found to be 0.1062
and 0.1060. The corresponding values for slopes in PBS (pH 7.4)
were 0.0929 and 0.0925. The slopes correlated well in two media
with R2 > 0.9995. These results revealed that any small change
in the drug concentration in the solutions could be accurately
determined by the proposed analytical methods.
3.2.3. Precision
Precision was determined by studying the repeatability and
intermediate precision. Repeatability (%R.S.D.) ranged from
0.35 to 0.66 and 0.30 to 0.55 in 0.1N HCl and phosphate
buffer medium, respectively, at all three levels of moxifloxacin
concentrations (Table 2). Repeatability results indicated the

255

precision under the same operating conditions over a short


interval of time and inter-assay precision. Intermediate precision expresses within-laboratory variations in different days
and in different instruments. In intermediate precision study,
%R.S.D. values were not more than 2.0% in all the cases
(Table 4). R.S.D. values found for both the analytical methods were well within the acceptable range indicating that
these methods have excellent repeatability and intermediate precision. %R.S.D. values for precision studies with real
samples of moxifloxacin eyedrops were found to be less
than 2.
3.2.4. Linearity
The linearity range for moxifloxacin estimation was found to
be 112 g ml1 (r2 = 0.9999) and 114 g ml1 (r2 = 0.9998)
in 0.1N HCl and phosphate buffer medium, respectively
(Table 1). Lower values of parameters like standard error (S.E.)
of slope and intercept (Table 1) indicated high precision of the
proposed methods. Also, the mean slope and intercept values
are within the 95% confidence interval. Goodness of fit of the
regression equations was supported by high regression coefficient values and lower calculated F-values (Table 1).
3.2.5. LOQ and LOD
In 0.1N HCl, LOD and LOQ were found to be 0.0402 and
0.1217 g ml1 and, in phosphate buffer the LOD and LOQ
were found to be 0.0384 g ml1 and 0.1163 g ml1 , respectively for moxifloxacin.
3.2.6. Robustness
Variation of pH of the selected media by 0.1 did not have
any significant effect on the absorbance value of the moxifloxacin. The mean %recovery (S.D.) values were found to be
101.03 (1.29) and 100.51 (0.97) in 0.1N HCl and phosphate
buffer media, respectively (Table 1). The moxifloxacin solution
in selected media exhibited no spectrophotometric changes over
a period of 24 h, when kept at room temperature (Fig. 3).
3.3. Estimation of formulations
In 0.1N HCl, the assay values of moxifloxacin for different
formulations ranged from 99.70% to 101.06% with standard
deviation not more than 0.64%. In phosphate buffer medium the
assay values of moxifloxacin for different formulations ranged
from 100.42% to 100.84% with standard deviation not more than
0.77%. Assay values of formulations were same as mentioned
in the label claim indicating that the interference of excipient
matrix is insignificant in estimation of moxifloxacin by proposed
analytical methods. The estimated drug content with low values
of standard deviation established the precision of the proposed
methods. The results obtained from the two analytical methods
were compared statistically (Table 5). The calculated Students
t-values and F-values did not exceed the tabulated values (for
eight degrees of freedom) indicating no significant difference
between the methods, as far as accuracy and precision are
concerned.

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4. Conclusion
The proposed analytical methods are simple, rapid, accurate,
precise and inexpensive and hence can be used for the routine
analysis of moxifloxacin in bulk, pharmaceutical formulations
and for dissolution samples of formulations. The sample recoveries from all formulations were in good agreement with their
respective label claims, which suggested non-interference of formulations excipients in the estimation. Moreover, the present
method is fast with respect to analysis time as compared to
sophisticated chromatographic techniques.
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