Simultaneous Spectrophotometric Estimation of Thiocolchicoside and Diclofenac Potassium in Combined Capsule Dosage Form

 

A.R. Umarkar1*, Y.M. Bagad1, N.S. Rewatkar2 and L.T. Thote2

1Shri Sureshdada Jain Institute of Pharmaceutical Education and Research Department of Pharmaceutical Chemistry, Jamner. (Jalgaon) M.S. Pin: 424206

2J.L.Chaturvedi College of Pharmacy, Electronic Zone Building MIDC Hingna Road Nagpur, Nagpur 440016 M.S.

*Corresponding Author E-mail: arumarkar@gmail.com

 

ABSTRACT:

Two simple, rapid, accurate and economical analytical methods have been developed for the simultaneous estimation of Thiocolchicoside and Diclofenac potassium in combined capsule dosage form. First method is based on the determination of Q-value and Second method is based on simultaneous equation method. Thiocolchicoside has absorbance maxima at 259 nm and Diclofenac potassium has absorbance maxima at 271 nm in distilled water and phosphate. The absorption ratio (Q-value) was determined at 264 nm (Iso-absorptivity point) and 259 nm (_max of Thiocolchicoside Both the drugs obey Beer’s law in the concentration ranges employed for these methods. Both the methods were found to be simple, rapid, and accurate and can be adopted in routine analysis of drugs in formulations. The accuracy and reproducibility of the proposed method was statistically validated by recovery studies.

 

KEYWORDS: Absorption ratio, Simultaneous equation, Overlain spectra, Recovery studies

 

 

INTRODUCTION:

Thiocolchicoside Chemically it is N-[3-(β-D-glucopyranosyloxy)-1,2-dimethoxy-10(methylthio)-9-oxo-5,6,7,9-tetrahydrobenzo [a] heptalen-7-yl] acetamide1. THC is a muscle relaxant. Its mode of action includes modulation of chemokine and prostanoid production and inhibition of neutrophil and endothelial cell adhesion molecules by which it interferes with the initiation and amplification of the joint inflammation.

 

Diclofenac potassium (DICP) chemically C14H10C12KNO2 and molecular weight 334.23. Chemically it is 2-[2,6dichlorophenylamino] benzene acetic acid potassium salt.2 Diclofenac potassium is an orally administered phenyl acetic acid derivative with effect on a variety of inflammatory mediators. It is the non steroidal ant inflammatory drug. Diclofenac potassium provides symptomatic relief in a variety of painful condition.

 

Literature survey reveals that Spectrophotometric HPLC, RP-HPLC methods are available for determination of Diclofenac Potassium from pharmaceutical preparations and biological formulation More ever, the literature survey revealed that so far, no method has been reported for estimation of THC and DICP in combined dosage form, hence two Spectrophotometric methods have been developed for simultaneous estimation of THC and DICP in capsule dosage form.3-9.

 

MATERIALS AND METHODS:

All the chemical used in the development of methods are of analytical grades. UV –Spectrophotometric used in this study is Shimadzu UV-1601 double beam spectrophotometer with 1.0 cm matched pair of rectangular quartz cells were used for spectrophotometric studies.

 

UV-Spectrophotometry:

Standard stock solution of Thiocolchicoside having concentration100μg/ml was prepared by dissolving 100ml distilled water and Diclofenac Potassium having concentration100μg/ml was prepared by dissolving 100 ml distilled water From this stock solution working standard solutions having concentration 10 μg/ml was prepared by appropriate dilution. Standard stock solution of THC and DICP having concentration 10 μg/ml was prepared from similar manner. Working Standard solutions of 10 μg/ml of each of the drug were canned in the range 200-400 nm. to obtained the absorbance graph for both the drug (Fig.1 and Fig.2) and the overlain spectra (Fig.3).

 

Absorption ratio method (Method-1):

Absorption ratio method 12,13,14 uses the absorbencies at two selected wavelengths, one of which is an isoabestic point and the other being the wavelength of maximum absorption of one of the two components. From the overlain spectra wavelength 264 nm (iso-bestic point) and 259 nm (_max of Thiocolchicoside) were selected for absorption ratio method. The absorbnces at 259 nm and 264 nm for THC were obtained. Similarly for DICP absorbencies are measured at 259 nm and 271 nm.The absorptivities value of each drug atboth wavelengths was also determined which the mean of five independent reading.

 

Fig. 1. Absorbance graph of Thiocolchicoside

 

The absorbances and absorptivity at these wavelengths were substituted in the following equation to obtained the concentration of both the drugs.

               CNT = (QM- Qy)/ (Qx-Qy)_ A1/ax1

COF = A1/ax1-CNT. Where THC and DICP are concentration of Thiocolchicoside and Diclofenaic potassium respectively, A1 is the absorbance of sample at 259, ax1 is the absorptivity of THC at 259 nm, Qx was obtained by using the equation- (absorptivity of THC at 264) / (absorptivity of THC at 259 nm).Qy was obtained from the equation-(absorptivity of DICP at 259 nm /absorptivity of DICP at 264 nm) and QM from (absorbance of sample at 264 nm/absorbance of sample at 259 nm).

 

Simultaneous Equation method (Method-2):

For selection of analytical wavelength for Simultaneous Equation Method 2,3,4 , the wavelength 271 nm (_max of DICP) and 259 nm (_max of THC) was selected. The absorbances of DICP and THC were measured at 271 nm and 259 nm. The absorptivities of both the drugs at both the wavelengths were also measured.

The absorbance and the absorptivity values at these particular wavelengths were calculated and substituted in the following equation, to obtain respective concentration.   THC= (A1 ax2- A2 ax1)/(ax2 ay1- ax1 ay2 )

               DICP = (A2 ay1 – A1 ay2 )/ (ax2 ay1- ax1 ay2)

Where, A1 is the absorbance of sample at 259 nm, A2 is the absorbance of sample at 271 nm, ax1 and ax2 are the absorptivity of THC at 259 nm and 271 nm respectively, ay1 and ay2 are the absorptivity of THC at 259 nm and 271 nm respectively, ay1 and ay2 are the absorptivity of DICP at 271 nm and 259 nm respectively.

 

 

Fig. 2: Absorbance graph of Diclofenac potassium

 

Figure  3. Overlain spectra of THC and DICP

 

Analysis of pharmaceutical Formulation:

For the simultaneous estimation of commercial formulation twenty capsule of THC(Labail claim: Thiocolchicoside 04 mg and Diclofenac potassium 50 mg) was taken. The average weight of capsule was determined. For method 1 and 2 powder equivalent to 10 mg THC was accurately weighed, transferred to a 10 ml volumetric flask, dissolved in 10ml solvent for 20 minutes with vigorous shaking. Finally the volume was made-up to the mark with solvent. The solution was filtered through Whatman filter paper-41, first few drops were rejected. The filtrate was then appropriately diluted to get final concentration of 2 _g/ml of and 5 _g/ml of THC. Absorbance of this solution was measured at appropriate wavelengths and values were substituted in the respective formula to obtain concentration. The result of analysis was mentioned in Table 1.

 

Recovery Study:

To check the accuracy of the developed methods and to study the interference of formulation additives, analytical recovery experiment was carried out by standard addition method. From the total amount of drug found, the percentage recovery was calculated. The results are reported in Table 2.

 

Table 1. Analysis Data of Tablet Formulation

Parameters.

Method 1.

Method 2.

THC

DICP

THC

DICP

Label claim(mg)

04

50

04

50

% of label Claim

100.10

99.45

99.86

100.40

± S.D.

1.112

0.723

1.261

0.612

% R.S.D

1.110

0.724

1.263

0.613

* Value for drug content (%) is the mean of three estimation. Method 1 is absorption ratio method, method 2 is simultaneous equation method, S.D is Standard deviation and R.S.D is relative standard deviation.

 

 

Table 2.  Recovery Studies

Methods

Excess drug

% Recovery*

% R.S.D

THC

DICP

THC

DICP

THC

DICP

Method

1

2

2

100.4

101.0

0.291

0.611

4

4

98.80

98.98

0.304

0.412

6

6

100.3

101.71

0.423

0.243

Method

2

2

2

100.4

101.2

0.413

0.254

4

4

100.3

99.67

0.642

0.410

6

6

99.6

99.82

0.632

0.096

* Recovery is mean of five estimation. Method 1 is absorption ratio method while Method 2 is simultaneous equation method and R.S.D is the relative standard deviation.

 

 

RESULT AND DISCUSSION:

Both the UV Spectrophotometric methods were found to be simple, accurate, economic and rapid for routine simultaneous estimation of THC and DICP, in capsule dosage forms. For both the methods, linearity was obtained in concentration range of 2-40 μg/ml and 1-50 μg/ml for THC and DICP respectively. Both the drug show good regression values at their respective wavelengths. Recovery was in the range of 99-101%; the value of standard deviation and % R. S. D are found to be < 2%; shows the high precession of the method.

 

 

ACKNOWLEDGEMENT:-

The authors are thankful to Head, J. L. Chaturvedi College of Pharmacy, Electronic Zone Building, MIDC Hingna Road, Nagpur for providing laboratory facilities. Authors are also thankful to Ajanta Pharma. Mumbai and Zim Laboratories Ltd. Kalmeshwar respectively.

 

REFERENCE:-

1.       Marydele jo Catherine M.K Maryann RD, The Merck index ,an Encyclopedia of chemicals, drugs ,and biologicals, Whitehouse station,N U, USA., 2006;14;  522-1602.

2.       Kathleen Parfti, Martindal. The complete drug reference, 35; 38; 1738.

3.       Rossol. Alberto Stefano zuccaro, Determination of alkaloids from the colchicines family by reversed phase high performance liquid chromatography. Journal of chromatography A, 1998; 825; 96-10

4.       Shankar MB, Shah M, Geetha FA. And Bhatt KK. Simultaneous Spectrophotometric determination of Tizanidin and Diclofenac in Tablets. Indian J. Pharm. Sci. 2004; 66; 332-335.

5.       Jeffery GH, Basset J, Mendham J, Denney RC, Vogel’s Textbook of Quantitative Analysis, Longman Scientific and Technical, 1999; 5.. 10.

6.       Pernarowski M, Knevel AM and Christian JE. Application ofabsorbancy ratios to the analysis of pharmaceuticals I.Theory of analysis of binary mixture J.Pharm.Sci 1960; 1: 943-948.

7.       Kasture VS, Bhagat AD, Puro NC, More PS. And Bhandari NK. Spectrophotometric Method for Simultaneous Estimation of Ofloxacin and Ornidazole in Tablet Dosage Form. Indian Drugs, 2004; 41; 51-53.

8.       Pattanayak P, Sharma R. and Chaturvedi SC. Simultaneous spectrophatometric estimation of Rabeprazole sodium and Itopride Hydrochloride Analytical Letters 2007; 44; 2288-2294.

9.       Kasture AV, Wadodkar SG, Mahadik KR, More HM, Pharmaceutical Analysis, 1997; 2; 1-5.

 

 

 

 

 

Received on 22.11.2010        Modified on 03.12.2010

Accepted on 21.12.2010        © AJRC All right reserved

Asian J. Research Chem. 4(3): March 2011; Page 370-372