Indian Journal of Pharmaceutical Sciences
Users online: 27
Scientific Publication of the Indian Pharmaceutical Association
Home Email this page Print this page Bookmark this page Decrease font size Default font size Increase font size
The Journal Search Current Issue Archives Instructions Online submission Login  


 
RESEARCH PAPER
Year : 2006  |  Volume : 68  |  Issue : 6  |  Page : 737-739
Development and validation of spectrophotometric methods for simultaneous estimation of tramadol hydrochloride and chlorzoxazone in tablet dosage form


Department of Quality Assurance, Institute of Pharmaceutical Education and Research, Borgaon (Meghe), Wardha-442 001, India

Correspondence Address:
Manisha Puranik
Department of Quality Assurance, Institute of Pharmaceutical Education and Research, Borgaon (Meghe), Wardha-442 001
India
Login to access the Email id


DOI: 10.4103/0250-474X.31005

Get Permissions

   Abstract 

Two simple, accurate, and precise methods for simultaneous estimation of tramadol hydrochloride and chlorzoxazone in combined dosage form have been described. The first method employs formation and solving of simultaneous equations using 272.20 and 248.30 nm as two analytical wavelengths. The second method is absorption ratio method, which uses 272.20 and 257.50 nm as two analytical wavelengths. Both the methods allow the simultaneous determination of tramadol hydrochloride and chlorzoxazone in concentration ranges employed for this purpose with the standard deviation of <1.0% in the assay of tablet.



How to cite this article:
Puranik M, Hirudkar A, Wadher S J, Yeole P G. Development and validation of spectrophotometric methods for simultaneous estimation of tramadol hydrochloride and chlorzoxazone in tablet dosage form. Indian J Pharm Sci 2006;68:737-9

How to cite this URL:
Puranik M, Hirudkar A, Wadher S J, Yeole P G. Development and validation of spectrophotometric methods for simultaneous estimation of tramadol hydrochloride and chlorzoxazone in tablet dosage form. Indian J Pharm Sci [serial online] 2006 [cited 2014 Nov 28];68:737-9. Available from: http://www.ijpsonline.com/text.asp?2006/68/6/737/31005


A new fixed dose combination containing tramadol hydrochloride (TRM) and chlorzoxazone (CLZ) is available in the market in tablet dosage form for relieving low back pain and cervical spondylosis. USP monograph describes high performance liquid chromatography (HPLC)[1] method for assay of CLZ tablet and European pharmacopoeia describes potentiometric[2] method for assay of TRM hydrochloride. Literature survey reveals that reports are available for estimation of TRM hydrochloride by GC[3] in plasma and brain tissue of mice and rats, using HPLC[4],[5],[6] in plasma and urine, and spectrohotometry[7],[8] in pharmaceutical formulations. Several spectrophotometric[9],[10] and HPLC[11],[12] methods are reported for estimation of CLZ in combination with other drugs from pharmaceutical formulations and biological fluid. However, no method is yet reported for simultaneous estimation of tramadol hydrochloride and chlorzoxazone in combined dosage form. Hence, two spectrophotometric methods have been developed to estimate these two drugs from tablet dosage form.


   Materials and methods Top


UV/Vis. double beam spectrophotometer, model- Shimadzu UV 2401 PC with 1 cm quartz cells was used.

Preparation of solutions:

TRM hydrochloride standard stock solution (0.6 mg/ml) was prepared by transferring accurately weighed 60 mg portion of TRM in 100 ml volumetric flask and volume was made up with 0.1 N NaOH in methanol to give concentration of 600 g/ml. CLZ standard stock solution (0.1 mg/ml) was prepared by transferring accurately 10 mg portion of CLZ in 100 ml volumetric flask and volume was made up with 0.1 N NaOH solution in methanol to give concentration of 100 g/ml.

Simultaneous equations method (Method 1):

Selection of analytical wavelengths was done by taking pure samples of TRM and CLZ which were separately dissolved in 0.1 N NaOH in methanol to give two solutions of 60 and 10 g/ml, respectively. They were scanned in the wavelength range of 200-400 nm. From the overlain spectra [Figure - 1], wavelengths 272.20 and 248.30 nm were selected for the formation of simultaneous equations. For constructing a calibration curves, two series of different concentrations in range of 30-300 g/ml for TRM and 5-50 g/ml for CLZ were prepared from stock solutions. The calibration curves were plotted at 272.20 and 248.30 nm. The absorptivities (A1%, 1 cm) of both the drugs at both the wavelengths were determined. These calculated values were the mean of five independent determinations.

The absorbance and absorptivities values at the particular wavelengths were calculated and substituted in the following equations to obtain the concentrations: A 1 = 0.56 10 2 Cx + 2.77 10 2 Cy- (1) and A 2 = 0.04 10 2 Cx + 4.01 10 2 Cy- (2), where A 1 and A 2 are absorbance of sample solution at 248.30 and 272.2 nm, respectively. Cx and Cy are concentration of TRM hydrochloride and CLZ, respectively (in mole/l) in sample solution. By substituting the value of Cx from Equation (1) into Equation (2), the value of Cy can be obtained. Now substituting this value of Cy in one of the equations, the value of Cx can be obtained. The validity of formed equations was checked by preparing five mixed standards, measuring their absorbances at respective wavelengths and comparing these with the absorbances calculated using above formed equations.

Absorption ratio method (Method 2):

From the overlain spectra of TRM and CLZ 272.20 nm was taken as λmax for TRM and 257.50 nm as isobestic point for estimation of TRM and CLZ, respectively. Series of different concentrations in range of 30-300 g/ml for TRM and 5-50 g/ml for CLZ were prepared from stock solutions. The calibration curves were plotted at 272.20 and 257.50 nm. The absorptivities (A1%, 1 cm) of both the drugs at both the wavelengths were determined. These calculated values were the mean of five independent determinations.

Estimation from tablets:

Twenty tablets of brand Muzox (Stedman Pharmaceuticals Ltd., Label claim CLZ 250 mg and 50 mg TRM) were weighed and finely powdered. Accurately weighed tablet powder equivalent to 100 mg was taken in 100 ml volumetric flask. To it 580 mg of pure TRM was added and sonicated for 5 min with 50 ml 0.1 N methanolic NaOH. The volume was made to mark. Aliquot portion of this solution was further diluted to achieve final concentration of 60 g/ml for TRM and 10 g/ml for CLZ. The absorbances were noted at respective wavelengths. The concentration of each drug in tablet formulation was determined using above methods.


   Results and discussion Top


The overlain spectra of TRM and CLZ in the concentration ratio of 6:1 showed that the peaks are well resolved thus satisfactory criteria for obtaining maximum precision based on absorbance ratios The criteria being the ratios (A 2 A 1 /aX 2 aX 1 ) for drug Y and (aY 2 aY 1 /A 1 A 2 ) for drug X should lie outside the range of 0.1-2.0 where A 1 and A 2 represent absorbance of tablet solution at λ 1 and λ 2, aX 1 and aX 2 represents absorptivities of X at λ 1 and λ 2 and aY 1 and aY 2 denote absorptivities of Y at λ 1 and λ 2, respectively. In the present contest, the above criteria found to be satisfied for TRM (X) and CLZ (Y) where λ 1 is 272.20 nm and λ 2 is 248.30 nm. In overlain spectra, CLZ shows two distinct peaks, one at around 248.30 and other at 292.00 nm. The peak at 248.30 nm was found to be prominent hence for simultaneous equations method; the peak was used for determination of CLZ. Since only one prominent peak exists for TRM at 272.20 nm, the same was used for its determination. Absorbance was determined at both the wavelengths. Calibration curves were plotted and regression analysis was carried out [Table - 1]. The absorbitivity was then calculated and substituted in Equations 1 and 2 along with absorbance values to obtain concentration of drugs.

In absorption ratio method, two wavelengths are selected from overlain spectra out of which one is isobestic point and another is λmax of one of the drugs. The spectra of TRM and CLZ when overlaid indicated that the isobestic point was at 257.50 nm at which estimation of CLZ was done and estimation of TRM was done at its λmax , 272.20 nm.

Both the methods were successfully used to estimate the amounts tramadol hydrochloride and chlorzoxazone in marketed tablet formulation containing tramadol hydrochloride 50 mg and chlorzoxazone 250 mg. The results obtained were comparable with the corresponding labeled amounts [Table - 2].

By observing the validation parameters [Table - 3], both the methods were found to be specific, accurate, precise, repeatable, and reproducible. However, Absorption ratio method has an advantage of simpler calculations over the simultaneous equations method. Hence, both methods can be employed for routine analysis of tablet for assay as well as dissolution testing.


   Acknowledgments Top


The authors thank Neon Laboratories Ltd., Palghar (Thane) for the sample of pure tramadol hydrochloride and Noble Drugs Ltd., Ambad (Nasik.) for sample of pure chlorzoxazone[13].

 
   References Top

1.The United States Pharmacopoeia 24, US Pharmacopoeial Convention, Rockville, 2000, 302   Back to cited text no. 1    
2.European Pharmacopoeia, 5th Edi., European Department for the Quality of Medicines within the Council of Europe, Strasbourg, 2005, 2607  Back to cited text no. 2    
3.Tao, Q., Stone , D.J., Borenstein, M.R., Jean, B., Valerie, C., Ellen, E., Timothy, P., Desai, K. D., Liao, S. and Raffa, R.B., J. Chromatogr., B , 2001, 763, 165  Back to cited text no. 3    
4.Pederson, R.S., Brosen, K. and Nielsen, F., Chromtographia , 2003, 57, 279   Back to cited text no. 4    
5.Nobilis, M., Kopecky, J., Kvetina, J., Chladek, J., Svoboda, Z., Varisek, V., Perlik, F., Pour, M. and Kunes, J., J. Chromatogr. A, 2002, 949, 11  Back to cited text no. 5    
6.Gan, S. H. and Ismail, R., J. Chromatogr. B, 2001, 759, 325  Back to cited text no. 6    
7.Abdellatef, H.E., J. Pharm. Biomed. Anal., 2002, 29, 835  Back to cited text no. 7    
8.Rajput, S .J. and Trivedi, P.D., Indian Drugs, 2001, 38, 100  Back to cited text no. 8    
9.Kale, U.N., Naidu, K.R. and Shingare, M.S., Indian J. Pharm. Sci., 2002, 64, 168  Back to cited text no. 9    
10.Mashru, R.C. and Banerjee, S.K., Eastern Pharmacist, 1998, 41, 141   Back to cited text no. 10    
11. Frey, R.F. and Stiff, D.D., J. Chromatogr. B, 1996, 686, 291  Back to cited text no. 11    
12.Gangawal, S. and Trivedi, P., Eastern Pharmacist, 2000, 45,139  Back to cited text no. 12    
13.International Conference on Harmonization, Guidance for Industry In; Q2B Validation of Analytical procedures: Methodology, 1996, 2  Back to cited text no. 13    


    Figures

[Figure - 1]

    Tables

[Table - 1], [Table - 2], [Table - 3]

This article has been cited by
1 Extractive spectrophotometric determination of tramadol hydrochloride in pure and pharmaceutical dosage forms
Rajitha, B., Prashanthi, S., Ramsubha Reddy, K., Tulja Rani, G.
International Journal of PharmTech Research. 2011; 3(1): 114-117
[Pubmed]
2 Simultaneous estimation of tramadol hydrochloride and paracetamol by UV spectrophotometric method from tablet formulation
Gharge, D., Dhabale, P.
International Journal of PharmTech Research. 2010; 2(2): 1119-1123
[Pubmed]
3 Simultaneous densitometric TLC analysis of aceclofenac, paracetamol, and chlorzoxazone in tablets
V. K. Mahajan, S. B. Bari, A. A. Shirkhedkar, S. J. Surana
Acta Chromatographica. 2008; 20(4): 625-636
[Pubmed]
4 Simultaneous densitometric analysis of tramadol hydrochloride and chlorzoxazone by high-performance thin-layer chromatography
Muruganathan Gandhimathi, Thengungal Kochupappy Ravi
JPC - Journal of Planar Chromatography - Modern TLC. 2008; 21(4): 305
[VIEW]
5 Simultaneous spectrophotometric estimation of rabeprazole sodium and Itopride HCl
Pattanayak, P., Sharma, R., Chaturvedi, S.C.
Analytical Letters. 2007; 40(12): 2288-2294
[Pubmed]
6 Simultaneous Spectrophotometric Estimation of Rabeprazole Sodium and Itopride HCl
P. Pattanayak,R. Sharma,S. C. Chaturvedi
Analytical Letters. 2007; 40(12): 2288
[Pubmed]



 

Top
Print this article  Email this article
 
  Search
   
   Next article
   Previous article 
   Table of Contents
  
    Similar in PUBMED
   Search Pubmed for
   Search in Google Scholar for
    Article in PDF (166 KB)
    Citation Manager
    Access Statistics
    Reader Comments
    Email Alert *
    Add to My List *
* Registration required (free)  


    Abstract
    Materials and me...
    Results and disc...
    Acknowledgments
    References
    Article Figures
    Article Tables

 Article Access Statistics
    Viewed6658    
    Printed89    
    Emailed9    
    PDF Downloaded567    
    Comments [Add]    
    Cited by others 6    

Recommend this journal