Research J. Pharm. and Tech. 1(4): Oct.-Dec.

2008,
,

www.rjptonline.org

ISSN 0974-3618

RESEARCH ARTICLE

Simultaneous Spectrophotometric Estimation of Satranidazole in Tablet Dosage Form

Wankhede SB*, Prakash A and Chitlange SS.
Pad. Dr. D. Y. Patil Institute of Pharmaceutical Sciences and Research, Sant Tukaram Nagar, Pimpri, Pune-18.
*Corresponding Author E-mail: sagar2277@rediffmail.com

ABSTRACT:
Three simple, precise and economical UV methods have been developed for the estimation of Satranidazole in tablet
dosage form. Satranidazole has the absorbance maxima at 320 nm (Method A), and in the first order derivative spectra,
showed sharp peak at 290 nm (Method B). Method C applied was area under curve (AUC) in the wavelength range of
325-315 nm. Linearity for detector response was observed in the concentration range of 5-35 g/ml for Method A and 540 g/ml for Method B and Method C. The proposed methods were successfully applied for the simultaneous
determination of Satranidazole in commercial tablet preparation. The results of the analysis were validated statistically
and by recovery studies and were found to be satisfactory.

KEY WORDS: Satranidazole, UV spectrophotometry, derivative spectroscopy, area under curve.

INTRODUCTION:
Satranidazole (SAT), is a novel nitro-imidazole derivative.
Chemically, it is 1-methylsulfonyl-3-(1-methyl-5-nitro-2imidazolyl)-2-imidazolidinone1. It is used as antiprotozoal
and antibacterial agent in the treatment of amoebiasis2.
Tablet formulation containing 300 mg SAT is available in
the market. Literature survey revealed that Satranidazole is
estimated by HPTLC3.4, HPLC5 and colorimetric methods68
and in combination with Ofloxacin9. No UV
spectrophotometric methods have been reported for
estimation of SAT in single component formulation.
Hence, an attempt has been made to develop new UV
methods for its estimation in pharmaceutical formulations
with good accuracy, simplicity, precision and economy.

MATERIAL AND METHODS:

Instrument: A double-beam Shimadzu UV- Visible
spectrophotometer, 1700 Pharmaspec, with spectral
bandwidth of 2 nm, wavelength accuracy 0.5 nm and a
pair of 1-cm matched quartz cells was used to measure
absorbance of the resulting solution.
Materials:
Standard gift sample of Satranidazole was provided by
Alkem Laboratories Limited, Baddi. Satranidazole tablets
(SATROGYL, 300 mg Satranidazole; manufacture by
Alkem Laboratories Limited, Baddi), were purchased
from local market.
Received on 22.08.2008
Accepted on 10.10.2008

Modified on 28.08.2008
RJPT All right reserved

Research J. Pharm. and Tech. 1(4): Oct.-Dec. 2008;Page 441-443

Solvent used: Double distilled water was used as a

solvent.
Stock solution: Standard stock solutions of SAT (100
g/ml) was prepared and used for the analysis.
Procedure:
Method A: Absorption Maxima Method:
For the selection of analytical wavelength, 25 g/ml
solution of SAT was prepared by appropriate dilution of
standard stock solution and scanned in the spectrum mode
from 400 nm to 200 nm. From the spectra of drugs (Fig.
1), max of SAT, 320.0 nm was selected for the analysis.
The calibration curve was prepared in the concentration
range of 5-35 g/ml at 320.0 nm. By using the calibration
curve, the concentration of the sample solution can be
determined.
Method B: First Order Derivative Spectroscopy:
In this method, 25 g/ml solution of SAT was prepared
by appropriate dilution of standard stock solution and
scanned in the spectrum mode from 400 nm to 200 nm.
The absorption spectra thus obtained were derivatized
from first to fourth order. First order derivative spectra
were selected for analysis of both drugs. First order
derivative spectra of drug (Fig. 2), showed a sharp peak
at 290.0 nm, which was selected for its quantitation. The
calibration curves for SAT was plotted in the
concentration range of 5-40 g/ml at wavelength 290.0
nm The concentration of the drug present in the mixture
was determined against the calibration curve in
quantitation mode.

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Method C: Area Under Curve Method:

For the selection of analytical wavelength, 25 g/ml
solution of SAT was prepared by appropriate dilution of
standard stock solution and scanned in the spectrum mode
from 400 nm to 200 nm. From the spectra of drugs, area
under the curve in the range of
325.0-315.0 nm was
selected for the analysis. The calibration curve was
prepared in the concentration range of 5-40 g/ml at their
respective AUC range. By using the calibration curve, the
concentration of the sample solution can be determined.
Application of the proposed method for the
determination of SAT in tablets:
For the estimation of drugs in the commercial formulations,
twenty tablets were weighed and average weight was
calculated. The tablets were crushed to obtain fine powder.
Tablet powder equivalent to 50 mg SAT was transferred to
100.0 ml volumetric flask and volume made up to the mark
with double distilled water and ultrasonicated for 20 minutes.
The solution was then filtered through a Whatmann filter
paper (No. 41). From the filtrate 5.0 ml was transferred to a
50.0 ml volumetric flask and diluted to the mark with the
same solvent. The solution was further diluted with double
distilled water to obtain 15 g/ml of SAT. In Method-A, the
concentration of SAT was determined by measuring the
absorbance of the sample at 320.0 nm in zero order spectrum
modes. By using the calibration curve, the concentration of
the sample solution can be determined. Method-B, the
concentration of SAT was determined by measuring the
absorbance of the sample at 290.0 nm, in first order
derivative mode. The results of the tablet analysis were
calculated against the calibration curve in quantitation mode.
For Method-C, the concentration of SAT was determined by
measuring area under curve in the range of 325.0-315.0 nm.
By using the calibration curve, the concentration of the
sample solution can be determined. Results of tablet analysis
are shown in Table No. 1.

Linearity: The linearity of measurement was evaluated

by analyzing different concentration of the standard
solution of SAT. Beer-Lamberts concentration range was
found to be 5-35 g/ml for Method A and 5-40 g/ml for
Method B and Method C.
Precision:
The reproducibility of the proposed method was
determined by performing tablet assay at different time
intervals (morning, afternoon and evening) on same day
(Intra-day assay precision) and on three different days
(Inter-day precision). Result of intra-day and inter-day
precision is expressed in % RSD. Percent RSD for
Intraday assay precision was found to be 0.2726, 0.5916
and 0.0552 for Method A, B and C, respectively. Interday assay precision was found to be 0.4030, 0.5926 and
0.1564 for Method A, B and C, respectively.
Fig.-1: Zero order spectra of Satranidazole

Fig.-2: First order derivative Spectra of Satranidazole

Table No. 1: Results of Analysis of Tablet Formulation

% Label
%
Label Amount of drug
Claim* Recovery
Method Drug
Claim estimated(mg/tab)
S.D.
*
99.38
A
SAT 300
298.13
99.34
0.2965
99.81
B
SAT 300
299.43
99.52
0.7966
99.81
C
SAT 300
299.43
99.29
0.2577

* indicates mean of six determinations.

Validation: The methods were validated with respect to
linearity, accuracy, precision and selectivity.
Accuracy: To ascertain the accuracy of proposed
methods, recovery studies were carried out by standard
addition method at three different levels (80%, 100% &
120%). Percent recovery for SAT, by all the methods, was
found in the range of 98.26 % to 100.48 %.

RESULTS AND DISCUSSION:

The methods discussed in the present work provide a
convenient and accurate way for simultaneous analysis of
Satranidazole in its pharmaceutical dosage form.
Absorbance maxima of Satranidazole at 320 nm (Method

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A) and in the first order derivative spectra, sharp peak at

290 nm (Method B) were selected for the analysis.
Method C was area under curve (AUC) and the
wavelength range for quantitation was 325-315 nm.
Linearity for detector response was observed in the
concentration range of 5-35 g/ml for Method A and 5-40
g/ml for Method B and Method C. Percent label claim
for SAT in tablet analysis, by all the methods, was found
in the range of 98.87 % to 100.98 %. Standard deviation
and coefficient of variance for six determinations of tablet
sample, by all the methods, was found to be less than
2.0 indicating the precision of both the methods.
Accuracy of proposed methods was ascertained by
recovery studies and the results are expressed as
%
recovery. Percent recovery for OFL and SAT, by all the
methods, was found in the range of 98.26 % to 100.48 %
values of standard deviation and coefficient of variation
was satisfactorily low indicating the accuracy of both the
methods. Based on the results obtained, it is found that the
proposed methods are accurate, precise, reproducible &
economical and can be employed for routine quality
control of Ofloxacin and Satranidazole in combined dose
tablet formulation.

9.

Satranidazole in pharmaceutical formulations. Indian J

Pharm Sci. 2001; 63: 433-436.
Wankhede SB, Nanda RK, Prakash A and Chitlange SS.
Simultaneous Spectrophotometric estimation of Ofloxacin
and Satranidazole in tablet dosage form. J Pharm Res. 2008;
7: 92-94.

ACKNOWLEDGEMENTS:
The authors are very thankful to Dr. Avinash D.
Deshpande, Director of Pharmacy, Pad. Dr. D. Y. Patil
Institute of Pharmaceutical Sciences and Research, Pimpri,
Pune for providing necessary facilities. The authors are also
thankful to Alkem Laboratories Limited, Baddi, for
providing gift samples of Satranidazole.

REFERENCES:
1.
2.
3.

4.

5.
6.

7.

8.

http://sci-toys.com/scichem/jqp016/41841.html.
Tripathi KD. Essentials of Medical Pharmacology. Jaypee
Brothers Medical Publishers (P) Ltd, New Delhi. 2004; 5th
ed: pp. 752.
Patel MB, Patel KM, Patel GS, Suhagia BN and Prajapati
AM. Development and validation of a stability-indicating
HPTLC-densitometric method for Satranidazole. J Liq
Chromatogr Rel Technol. 2007; 30: 2459-2471.
Lalla J, Hamrapurkar P, Anu. R and Wadhwa T. Highperformance thin-layer chromatographic determination of
Satranidazole in its dosage form. JPC- J Planar ChromatogrModern TLC. 2003; 16: 447-450.
Natarajan S and Raman B. HPLC determination of
Satranidazole in bulk and pharmaceutical dosage forms.
Asian J Chem. 2008; 20: 1833-1840.
Mruthyunjayaswamy BHM, Patil SMM and Raju SA.
Spectrophotometric determination of Satranidazole in bulk
drug and formulations. J Indian Chem Soc. 2003; 80: 863865.
Raju SA, Shobha M and Manjunath S. Spectrophotometric
methods for the estimation of Satranidazole in
pharmaceutical formulation. Asian J Chem. 2002; 14: 520522.
Mruthyunjayaswamy BHM, Patil SMM and Raju SA.
Spectrophotometric methods for the estimation of

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