Simultaneous Spectrophotometric Estimation of Satranidazole in Tablet Dosage Form

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Research J. Pharm. and Tech. 1(4): Oct.-Dec. 2008,

,

441

ISSN 0974-3618 www.rjptonline.org

RESEARCH ARTICLE

Simultaneous Spectrophotometric Estimation of Satranidazole in Tablet Dosage FormWankhede 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: [email protected]

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 of325-315 nm. Linearity for detector response was observed in the concentration range of 5-35 µg/ml for Method A and 5-

40 µg/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 statisticallyand 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-2-

imidazolyl)-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 methods6-

8 and in combination with Ofloxacin9. No UVspectrophotometric 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 formulationswith 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 byAlkem 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 Modified on 28.08.2008Accepted on 10.10.2008 © 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 asolvent.

Stock solution: Standard stock solutions of SAT (100

µg/ml) was prepared and used for the analysis.

Procedure:

Method A: Absorption Maxima Method:

For the selection of analytical wavelength, 25 µg/m

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), λ max of SAT, 320.0 nm was selected for the analysis

The calibration curve was prepared in the concentrationrange of 5-35 µg/ml at 320.0 nm. By using the calibration

curve, the concentration of the sample solution can bedetermined.

Method B: First Order Derivative Spectroscopy:

In this method, 25 µg/ml solution of SAT was prepared

by appropriate dilution of standard stock solution and

scanned in the spectrum mode from 400 nm to 200 nmThe absorption spectra thus obtained were derivatized

from first to fourth order. First order derivative spectra

were selected for analysis of both drugs. First orderderivative 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 theconcentration range of 5-40 µg/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 µg/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, areaunder 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 µg/ml at their

respective AUC range. By using the calibration curve, theconcentration 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 thesame solvent. The solution was further diluted with doubledistilled water to obtain 15 µg/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, theconcentration of SAT was determined by measuring the

absorbance of the sample at 290.0 nm, in first orderderivative 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 thesample solution can be determined. Results of tablet analysis

are shown in Table No. 1.

Table No. 1: Results of Analysis of Tablet Formulation

Method DrugLabel

Claim

Amount of drug

estimated(mg/tab)

% Label

Claim*±

S.D.

%

Recovery

*

A SAT 300 298.1399.38±

0.296599.34

B SAT 300 299.4399.81±

0.796699.52

C SAT 300 299.4399.81±

0.257799.29

* 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 %.

Linearity: The linearity of measurement was evaluated by analyzing different concentration of the standard

solution of SAT. Beer-Lambert’s concentration range was

found to be 5-35 µg/ml for Method A and 5-40 µg/ml for

Method B and Method C.

Precision:

The reproducibility of the proposed method was

determined by performing tablet assay at different timeintervals (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. Inter

day 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

RESULTS AND DISCUSSION:The methods discussed in the present work provide a

convenient and accurate way for simultaneous analysis ofSatranidazole 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 at290 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 theconcentration range of 5-35 µg/ml for Method A and 5-40

µg/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 deviationand 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 variationwas 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 dosetablet formulation.

ACKNOWLEDGEMENTS:The authors are very thankful to Dr. Avinash D.

Deshpande, Director of Pharmacy, Pad. Dr. D. Y. PatilInstitute 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. http://sci-toys.com/scichem/jqp016/41841.html.

2.

Tripathi KD. Essentials of Medical Pharmacology. JaypeeBrothers Medical Publishers (P) Ltd, New Delhi. 2004; 5thed: pp. 752.

3. Patel MB, Patel KM, Patel GS, Suhagia BN and Prajapati

AM. Development and validation of a stability-indicatingHPTLC-densitometric method for Satranidazole. J LiqChromatogr Rel Technol. 2007; 30: 2459-2471.

4. Lalla J, Hamrapurkar P, Anu. R and Wadhwa T. High- performance thin-layer chromatographic determination ofSatranidazole in its dosage form. JPC- J Planar Chromatogr-

Modern TLC. 2003; 16: 447-450.

5. Natarajan S and Raman B. HPLC determination ofSatranidazole in bulk and pharmaceutical dosage forms.

Asian J Chem. 2008; 20: 1833-1840.

6. Mruthyunjayaswamy BHM, Patil SMM and Raju SA.

Spectrophotometric determination of Satranidazole in bulkdrug and formulations. J Indian Chem Soc. 2003; 80: 863-865.

7. Raju SA, Shobha M and Manjunath S. Spectrophotometricmethods for the estimation of Satranidazole in

pharmaceutical formulation. Asian J Chem. 2002; 14: 520-522.

8. Mruthyunjayaswamy BHM, Patil SMM and Raju SA.Spectrophotometric methods for the estimation of

Satranidazole in pharmaceutical formulations. Indian Pharm Sci. 2001; 63: 433-436.

9. Wankhede SB, Nanda RK, Prakash A and Chitlange SSimultaneous Spectrophotometric estimation of Ofloxacand Satranidazole in tablet dosage form. J Pharm Res. 2007: 92-94.

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Simultaneous Spectrophotometric Estimation of Satranidazole in Tablet Dosage Form