Analytical & Bioanalytical Reddy et al.

J Anal Bioanal Techniques 2011, 2:3

http://dx.doi.org/10.4172/2155-9872.1000121
Techniques

Research Article Open Access

Rapid Simultaneous Determination of Sumatriptan Succinate and Naprox-

en Sodium in Combined Tablets by Validated Ultra Performance Liquid
Chromatographic Method
Yarram Ramakoti Reddy1*, Kakumani Kishore Kumar1, MRP Reddy2 and K. Mukkanti1
1
Centre for Chemical Science and Technology, Institute of science and Technology, Jawaharlal Nehru Technological University, Hyderabad 500085, India
2
Centre for Meterials for Electronics Technology IDA, HCL post, Cherlapally, Hyderabad, India

Abstract
A stability- indicating ultra perfomance liquid chromatography (UPLC) method was developed for the
simultaneous determination of sumatriptan succinate and Naproxen sodium in pharmaceutical dosage forms. The
chromatographic separation was achieved on C18, 50 mm 4.8 mm, 1.8-m particle size column. The mobile
phase contains a mixture of 0.2% ortho phosphoric acid and acetonitrile as the mobile phase in gradient elution
technique. The retention time of Sumatriptan and Naproxen was found to be 1.7 and 2.7 min respectively. The total
runtime was 5 min within which two active compounds and degradation products were separated. This method
allows the determination of 850-2565 g mL-1 of sumatriptan succinate and 5000-15000 g mL-1 of Naproxen
sodium. The flow rate was 1.0 mL min-1 and the detection wavelength was 225 nm. The limit of detection (LOD) for
sumatriptan succinate and Naproxen sodium was 1.9 and 1.5 g mL-1, respectively. The limit of quantification (LOQ)
for sumatriptan succinate and Naproxen sodium was 6.3 and 4.8 g mL-1, respectively. This method was validated
for accuracy, precision, linearity and robustness. sumatriptan succinate and Naproxen sodium were subjected to
different ICH prescribed stress conditions of oxidative, acid, base, hydrolytic, thermal and photolytic degradation and
the method was also found to be stability indicating.

Keywords: Method development and validation; Simultaneous
sumatriptan succinate; Naproxen sodium stability-indicating.
Introduction
Sumatriptan succinate (SS) is a selective 5-hydroxytryptamine
(5-HT) receptor subtype agonist. Chemically it is known as
3-[2-(dimethylamino) ethyl]-N-methyl-indole-5-methanesulfonamide
succinate (1:1). The empirical formula is C14H21N3O2SC4H6O4,
representing a molecular weight of 413.5. It is indicated for indicated
for the acute treatment of migraine attacks with or without aura in
adults.
Naproxen sodium (NS) is a member of arylacetic acid group of
(a) Naproxen sodium
nonsteroidal anti-inflammatory drugs (NSAIDS). Chemically it is
(S)-6-methoxy--methyl-2-naphthaleneacetic acid, sodium salt. The
empirical formula is C14H13NaO3, representing a molecular weight of
252.23.
A tablet formulation containing 85 mg of Sumatriptan succinate
and 500 mg of Naproxen sodium has recently been approved for the
acute treatment of migraine. The combination product was proved to
have superior efficacy compared to its individual components for the
acute treatment of migraine. Sumatriptan, work early in the migraine
process at the trigeminovascular unit as agonists of the serotonin
receptors (5-HT receptors) 1B and 1D. They block vasoconstriction
and block transmission of signals to the trigeminal nucleus and thus
prevent peripheral sensitization. The analgesic effect of Naproxen
sodium helps relieve the headache, while the anti-inflammatory effect
decreases the neurogenic inflammation in the trigeminal ganglion,
thus preventing the development of central sensitization.
So far, several liquid chromatography procedures have been
described for the determination of SS and NS [1-19]. But, these
procedures were developed to estimate either SS or NS individually

(b) Sumatriptan succinate *Corresponding author: Yarram Ramakoti Reddy, Centre for Chemical
Science and Technology, Institute of science and Technology, Jawaharlal Nehru
Technological University, Hyderabad 500085, India, Tel: (+)91 9849392039;
E-mail: rramakoti48@yahoo.com, yrkccst@gmail.com

ReceivedApril 18, 2011; Accepted May 28, 2011; Published May 30, 2011

Citation: Reddy YR, Kumar KK, Reddy MRP, Mukkanti K (2011) Rapid
Simultaneous Determination of Sumatriptan Succinate and Naproxen Sodium
in Combined Tablets by Validated Ultra Performance Liquid Chromatographic
Method. J Anal Bioanal Techniques 2:121. doi:10.4172/2155-9872.1000121

Copyright: 2011 Reddy YR, et al. This is an open-access article distributed under
the terms of the Creative Commons Attribution License, which permits unrestricted
Figure 1: Chemical structures of Naproxen sodium and Sumatriptan succinate. use, distribution, and reproduction in any medium, provided the original author and
source are credited.

J Anal Bioanal Techniques

ISSN:2155-9872 JABT, an open access journal Volume 2 Issue 3 1000121
Citation: Reddy YR, Kumar KK, Reddy MRP, Mukkanti K (2011) Rapid Simultaneous Determination of Sumatriptan Succinate and Naproxen Sodium
in Combined Tablets by Validated Ultra Performance Liquid Chromatographic Method. J Anal Bioanal Techniques 2:121. doi:10.4172/2155-
9872.1000121
and in combination with other drugs from formulation, plasma, urine,
intestinal perfusion samples and in bulk drugs. For simultaneous
determination of SS and NS in formulation, there are two spectrometric
methods [20-21] and an HPTLC [22] method was reported. Whereas
no single liquid chromatographic (LC) method has been reported for
their simultaneous estimation from the combined tablets. Hence, it is
necessary to develop a rapid, accurate and validated LC method for
the simultaneous determination of SS and NS from combined dosage
form.
Ultra performance liquid chromatography (UPLC) is a recent
technique in liquid chromatography, which enables significant
reductions in separation time and solvent consumption. Literature
indicates that UPLC system allows about ninefold decrease in analysis
time as compared to the conventional HPLC system using 5m particle
size analytical columns, and about threefold decrease in analysis time
in comparison with 3m particle size analytical columns without
compromise on overall separation [23-27].
Hence, a rapid, accurate stability indicating UPLC method for the
simultaneous determination of SS and NS from combined dosage form
was developed and validated.
Experimental
Instrumentation and chromatographic conditions
The Waters UPLC Acquity system we used consists of a binary
solvent manager, a sample manager and a UV detector. Zorbax SB
C-18, 50 mm x 4.6 mm i.d with 1.8m particles was used as stationary
phase. 0.2% ortho phosphoric acid in water (pH 2.2) as solvent A and
acetonitrile and water in the ratio 90:10; v/v, was as solvent B used for
mobile phase. Prior to use, the mobile phase was mixed thoroughly
and degassed. The gradient program was set as B: 0/5, 2/95, 4/95, 4.1/5,
5.0/5. The mobile phase pumped at 1.0 mL min-1. The eluants were
monitored at 225nm. The injection volume for samples and standards
were 2L. Methanol, acetonitrile and water in the ratio, 40:40:20; v/v/v,
respectively was used as diluent.
Reagents
Standards were supplied by D.C.O. Hyderabad, India. HPLC grade
acetonitrile, analytical grade ortho phosphoric acids were purchased
from Merck (Mumbai, India). Water was prepared by Millipore
MilliQ Plus water purification system. Commercial pharmaceutical
preparation of Triximet combined tablets were purchased from the
market. The declared content of tablets was Sumatriptan 85 mg and
Naproxen 500 mg per tablet.
Preparation of solutions
Standard solutions: A standard solution containing 68g/mL-1
of SS and 400g/mL-1 of NS were prepared by dissolving appropriate
amount of SS and NS in diluent. All the solutions were covered with
aluminium foil to prevent photolytic reaction until the time of analysis.
Sample preparation: Ten tablets, each containing 85 mg of SS and
500 mg of NS were dissolved in 500 mL diluents to get 1710g mL-1
of SS and 10000g mL-1 of NS. 4 mL of above solution was diluted to
100 mL to get 68g mL-1 of SS and 400g mL-1 of NS. The solution
was filtered through 0.45 m Millipore PVDF filter. Then 2L of these
solutions were injected in the column and chromatogram was. The
retention times of SS and NS were found to be 1.8 min and 2.6 min,
respectively.
J Anal Bioanal Techniques
ISSN:2155-9872 JABT, an open access journal
Page 2 of 6
System suitability solution criteria
The system suitability was assessed by five replicate analyses of the
drugs at concentrations of 68g mL-1 of SS and 400g mL-1 of NS. The
acceptance criteria was not more than 2.0% for the RSD for the peak
areas and not more than 2.0 for tailing factor for the peaks of the both
the drugs.
Method validation
Method validation was performed as per ICH guidance [28-29]
for simultaneous determination of SS and NS in the formulations. The
following validation characteristics were addressed: linearity, detection
limit, quantification limit, precision, accuracy and specificity.
System suitability criteria
The system suitability test solution was injected and the
chromatographic parameters like relative standard deviation for
replicate injections of both SS and NS and the tailing factor for SS and
NS peaks were evaluated for proving the system suitability.
Specificityforced degradation studies
Forced degradation studies were performed on SS and NS combined
tablets to prove the stability indicating property of the method. The
stress conditions employed for degradation study of SS and NS include
light exposure [29], heat (105C), acid hydrolysis (1 N HCl at 50C),
base hydrolysis (1N NaOH at 50C), water hydrolysis at 50C and
oxidation (1% H2O2 at 30C). For light studies, the monitoring period
was 10 days whereas for heat, acid, base and water hydrolysis it was
48 h. Oxidation was carried out for 24h. Peak purity of the principal
peak in the chromatogram of stressed samples of SS and NS tablets was
checked using photo diode array detector.
Linearity of response
Linearity solutions were prepared from stock solution at five
concentration levels from 34g mL-1 to 102g mL-1 for SS and from
200g mL-1 to 600g mL-1 for NS. The slope, Y-intercept and correlation
coefficient were calculated.
Precision
Repeatability (intra-day): The precision of the assay method was
evaluated by carrying out six independent assays of SS and NS (1.71
mg mL-1 of SS and 10.0 mg mL-1 of NS) test samples against qualified
reference standard. The percentage of RSD of six assay values was
calculated.
Intermediate precision (inter-day): Different analyst from the
same laboratory evaluated the intermediate precision of the method.
This was performed by assaying the six samples of SS and NS tablets
against qualified reference standard. The percentage of RSD of six assay
values was calculated.
Accuracy (Recovery study)
Recovery of the assay method for SS and NS was established by
three determinations of test sample using tablets at 50%, 100% and
150% of analyte concentration (1.71 mg mL-1 of SS and 10.0 mg mL-1 of
NS). Each solution was injected trice (n=3) into HPLC system and the
average peak area of S and NS peaks was calculated.
Limit of Detection (LOD) and Limit of Quantification (LOQ)
The LOD and LOQ for SS and NS were estimated at a signal-to-
Volume 2 Issue 3 1000121
Citation: Reddy YR, Kumar KK, Reddy MRP, Mukkanti K (2011) Rapid Simultaneous Determination of Sumatriptan Succinate and Naproxen Sodium
in Combined Tablets by Validated Ultra Performance Liquid Chromatographic Method. J Anal Bioanal Techniques 2:121. doi:10.4172/2155-
9872.1000121
Figure 2: A typical chromatograms obtained from Naproxen sodium and Sumatriptan succinate tablets and from stressed samples.
noise ratio of 3:1 and 10:1, respectively, by injecting a series of dilute
solutions with known concentration.
Robustness
To determine the robustness of the method the experimental
conditions were deliberately changed and the resolution of SS and NS,
tailing factor and % RSD for five replicate injections was evaluated. The
mobile phase flow rate was 1.0mLmin1; to study the effect of flow rate
on resolution it was changed to 0.9 and 1.1 mLmin1. The effect of pH
was studied at pH 2.1 and 2.3 (instead of pH 2.2). The effect of column
temperature was studied at 25 and 35C (instead of 30C). In all these
experiments the mobile phase components were not changed.
Solution stability and mobile phase stability
The stability of SS and NS in solution was determined by leaving
test solutions of the sample and reference standard in tightly capped
volumetric flasks at room temperature for 48h during which they were
assayed at 24h intervals. Stability in the mobile phase was determined
by analysis of freshly prepared sample solutions at 24h intervals for 48h
and comparing the results with those obtained from freshly prepared
J Anal Bioanal Techniques
ISSN:2155-9872 JABT, an open access journal
Page 3 of 6
reference standard solutions. The mobile phase was prepared at the
beginning of the study period and not changed during the experiment.
The RSD (%) of the results was calculated for both the mobile phase
and solution-stability experiments.
Method development and optimization of stability indicating
assay method
The method was optimized to separate major degradation products
formed under varies stress conditions from SS and NS. The main target
of the chromatographic method is to get the separation for closely
eluting degradation products, mainly for the degradation product at 3.18
RT, which is eluting very closely to the NS. The degradation samples
were run using different stationary phases like C18, C8 and Mobile
phases containing buffers like phosphate and acetate with different
pH (2-7) and using organic modifiers like acetonitrile and methanol
in the mobile phase. But the separation was satisfactory in the adopted
chromatographic conditions only. It indicated that the gradient elution
with 0.2% ortho phosphoric acid in water as solvent A and acetonitrile
and water in the ratio 90:10; v/v, was as solvent B for mobile phase was
successful in separating drugs and all chromatographic degradation
products (Figure 2). The detailed experimentation is reported in Table 1.
Volume 2 Issue 3 1000121
Citation: Reddy YR, Kumar KK, Reddy MRP, Mukkanti K (2011) Rapid Simultaneous Determination of Sumatriptan Succinate and Naproxen Sodium
in Combined Tablets by Validated Ultra Performance Liquid Chromatographic Method. J Anal Bioanal Techniques 2:121. doi:10.4172/2155-
9872.1000121

Page 4 of 6

Results and Discussion of the procedure meet the requirements for the intended analytical
applications [28].
Method validation
System suitability
Validation of an analytical procedure is the process by which it is
established, by laboratories studies, that the performance characteristics The system suitability test solution was injected and the

UPLC
Trial no. Remarks
Conditions
Column Inertsil ODS-3, 50mm2.1mm, 2m particles
Solvent A: 0.2% ortho phosphoric acid in water (pH 2.2)
Mobile phase
1 Solvent B: Acetonitrile and water in the ratio 90:10 v/v Separation of unknown impurity (RT 3.18) from NS is poor
Flow rate 1.0 mL min-1
Gradient Time (min) / % solution B: 0/5, 2/95, 4/95, 4.1/5, 5.0/5
Column Waters AQUITY BEH C8, 50mm2.1mm, 1.7m particles
Solvent A: 0.2% ortho phosphoric acid in water (pH 2.2)
Mobile phase
2 Solvent B: Acetonitrile and water in the ratio 90:10 v/v Separation of unknown impurity (RT 3.18) from NS is poor
Flow rate 1.0 mL min-1
Gradient Time (min) / % solution B: 0/5, 2/95, 4/95, 4.1/5, 5.0/5
Column Zorbax SB C-18 column, 50mm2.1mm, 1.8m particles
Solvent A: 0.01 M KH2PO4 buffer, tetra hydro furan and methanol in the ratio
Mobile phase 67: 23: 10 (v/v/v), pH adjusted to 4.0 with ortho phosphoric acid. NS Peak is strongly retained and tailing of NS is more (1.8)
3 Solvent B: Acetonitrile and water in the ratio 90:10 v/v
0.6 mL min-1
Flow rate
Gradient Time (min) / % solution B: 0/5, 2/95, 4/95, 4.1/5, 5.0/5
Column Zorbax SB C-18 column, 50mm2.1mm, 1.8m particles
Solvent A: 0.01 M ammonium acetate buffer pH adjusted to 7.0 with
Mobile phase aqueous ammonia solution
NS Peak is strongly retained and tailing of NS is more (1.9)
4 Solvent B: Acetonitrile and water in the ratio 90:10 v/v
Flow rate 1.0 mL min -1

Gradient
Time (min) / % solution B: 0/5, 2/95, 4/95, 4.1/5, 5.0/5
program
Column Zorbax SB C-18 column, 50mm2.1mm, 1.8m particles
Solvent A: 0.2% ortho phosphoric acid in water (pH 2.2)
Mobile phase
Solvent B: Acetonitrile and water in the ratio 90:10 v/v Separation of unknown impurity (RT 3.18) from NS is
5
Flow rate 1.0 mL min-1 satisfactory and tailing for both SS and NS peaks were less than
1.3
Gradient
Time (min) / % solution B: 0/5, 2/95, 4/95, 4.1/5, 5.0/5
program
Table 1: Results from different method development trials.

Mean area Response Response calculated thru Trend line Residual (Response practical -Response
Concentration in g/ml Residual square
achieved equation theoretical)
34.2 294426 288932.80 -5493.2 98899047.0
51.3 430896 436335.20 5439.2 1133160.3
68.4 580852 583737.60 2885.6 207613517.4
85.5 731256 731140.00 -116.0 200366856.0
102.6 881258 878542.40 -2715.6 308163981.2
Residual sum of squares 75474769.6
Correlation coefficient 0.999
Trend line equation y = 8620x - 5872
Table 2: linearity.
Table 2a: Residual summary of Linearity results of Sumatriptan succinate

Mean area Response Response calculated thru Trend Residual (Response practical
Concentration in g/ml Residual square
achieved line equation -Response theoretical)
203.2 2245986 2236041.20 -9944.8 98899047.0
304.8 3361852 3360787.50 -1064.5 1133160.3
406.4 4471125 4485533.80 14408.8 207613517.4
508 5596125 5610280.10 14155.1 200366856.0
609.6 6752581 6735026.40 -17554.6 308163981.2
Residual sum of squares 816176561.9
Correlation coefficient 0.999
Trend line equation y = 11070x - 13451
Table 2b: Residual summary of Linearity results of Naproxen sodium

J Anal Bioanal Techniques

ISSN:2155-9872 JABT, an open access journal Volume 2 Issue 3 1000121
Citation: Reddy YR, Kumar KK, Reddy MRP, Mukkanti K (2011) Rapid Simultaneous Determination of Sumatriptan Succinate and Naproxen Sodium
in Combined Tablets by Validated Ultra Performance Liquid Chromatographic Method. J Anal Bioanal Techniques 2:121. doi:10.4172/2155-
9872.1000121

Page 5 of 6

% RSD for Assay variance across all concentrations suggesting the homoscedastic
S.No Parameter Variation Sumatriptan Naproxen nature of data. Selected linear model with univariant regression
succinate sodium showed minimum % bias indicating goodness of fit which was further
(a) Analyst-1 supported by the low standard error of estimate and mean sum of
Repeatability (b) Waters Acquity UPLC system 0.7 0.4
1
(inter-day) with PDA detector. residual squares.
(c) Day-1
(a) Analyst-2
Precision
Intermediate
(b) Waters Acquity UPLC system 0.6 0.4
2 precision The precision of an analytical method gives information on
with tunable UV detector.
(intra-day) the random error. It expresses of agreement between a series
(c) Day-2
Table 3: Precision results.
of measurements obtained from multiple sampling of the same
homogeneous sample under prescribed conditions. The percentage
Mean recovery (%) (n = 3) % RSD RSD values for the precision study was 0.7%, 0.4% (inter-day precision)
S.No Concentration (%)
SS NS SS NS and 0.6%, 0.7% (intra-day precision) for SS and NS, respectively. This is
1 50 99.8 99.9 0.31 0.22 confirming good precision of the method (Table 3).
2 100 99.3 101.0 0.20 0.28
3 150 100.3 100.2 0.25 0.26
Accuracy-recovery test
SS = Sumatriptan succinate The percentage recovery of SS was ranged from 98.2 to 100.2 and
NS = Naproxene sodium NS was ranged from 99.8 to 101.6. Excellent recoveries were made at
Table 4: Recovery study. each added concentration (Table 4).
Temperature Flow rate Limit of Detection (LOD) and Limit of Quantification (LOQ)
Parameter ( 5C of set ( 0.1 ml/min of the pH ( 1 unit)
temperature) set flow) The limit of detection of SS and NS was 1.9 and 1.5g /mL-1,
Variation 20C 30C 0.6 ml/min
0.8 ml/
95% 105% respectively for 2L injection volume. The limit of quantification of SS
min
and NS was 6.3 and 4.8g /mL-1, respectively for 2L injection volume.
% RSD for 5 SS 1.3 1.2 1.4 1.1 1.2 1.2
replicate injections NS 1.2 1.2 1.2 1.1 1.3 1.2 Robustness
USP Resolution
SS & NS 5.2 5.8 5.5 5.7 5.0 5.9 When mobile phase flow rate, pH and column temperature were
between
Table 5: Robustness Study
deliberately varied resolution between SS and NS was greater than 3.0,
tailing factor and % RSD for five replicate injections of SS and NS was
S.No Interval % Assay Solution stability % Assay Mobile phase stability less than 1.5, illustrating the robustness of the method (Table 5).
1 0h 99.4 98.2
Stability in solution and in the mobile phase
3 24 h 99.0 98.1
5 48 h 98.2 98.3 RSD (%) for assay of SS and NS during solution stability and mobile
% RSD 0.6 0.1 phase stability experiments was within 0.9%. No significant changes in
Table 6: Solution and mobile phase stability results. the amounts of the two drugs were observed during solution stability
and mobile phase experiments. The results from solution stability
Stress condition Time ~% Degradation and mobile phase stability experiments confirmed that standard
Acid hydrolysis (1N HCl,50C ) 24 h 11.2 % solutions and e mobile phase were stable for up to 48h during assay
Base hydrolysis (1N NaOH, 50C ) 24 h 5.3 %
determination (Table 6).
Oxidation (1% H202) 24 h 0.4%
Water hydrolysis (50C) 24 h 0.5% Specificityforced degradation studies
Thermal (105C) 24 h 0.3%
Degradation was not observed in SS and NS stressed samples
Light (photolytic degradation) 10 days 0.2%
that were subjected to light, heat, water and oxidation. However, the
Table 7: Forced degradation results.
degradation was observed under base hydrolysis and acid hydrolysis.
chromatographic parameters like relative standard deviation for The peak purity test results derived from PDA (Photo Diode
replicate injections of I and DC and the tailing factor for both SS and Array detector) confirmed that the SS and NS peaks were pure and
NS peaks are evaluated. The relative standard deviation for replicate homogeneous in all the analyzed stress conditions. This indicates that
injections of both SS and NS was 0.5% and 0.3% respectively. The the method is specific and stability indicating (Figure 2 and Table 7).
tailing factor for both SS and NS peaks was 1.2% and 1.3%, respectively. Conclusion
This indicates the suitability of the system.
A simple specific stability indicating liquid chromatographic
Linearity of response method is developed for the quantification of SS and NS simultaneously
Calibration curve obtained by least square regression analysis in combined dosage forms. This method is validated and it is found to
between average peak area and the concentration showed (Table 2a be specific, precise, accurate, robust and linear for the detection and
and Table 2b) linear relationship with a regression coefficient of 0.999. quantification of SS and NS. The method is stability-indicating and can
The best fit linear equation obtained was Y =8620 Con - 5872 for SS be used for routine analysis of production samples and to check the
and Y=11070 Con - 13451 for NS. Analysis of residuals indicated that stability of samples of SS and NS simultaneously in combined dosage
the residuals were normally distributed around the mean with uniform forms.

J Anal Bioanal Techniques

ISSN:2155-9872 JABT, an open access journal Volume 2 Issue 3 1000121
Citation: Reddy YR, Kumar KK, Reddy MRP, Mukkanti K (2011) Rapid Simultaneous Determination of Sumatriptan Succinate and Naproxen Sodium
in Combined Tablets by Validated Ultra Performance Liquid Chromatographic Method. J Anal Bioanal Techniques 2:121. doi:10.4172/2155-
9872.1000121
Acknowledgement
The authors are very grateful to C-MET for their continuous support for this
research work.
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