Potassium Ferricynide and Ferric Chloride: A Chromogenic Reagent for Estimation of Tranexamic Acid by Spectrophotometry

 

1Mohite PB*, 1Pandhare RB, 1Khanage SG and 2Bhaskar VH

1M.E.S. College of Pharmacy, Sonai, Ahmednagar, Maharashtra-414105 India

2MP Patel College of Pharmacy, Kapadwanj ,Gujarat  India

*Corresponding Author E-mail: popatmohite2006@yahoo.co.in

 

 

ABSTRACT

A simple, accurate and reproducible spectrophotometric method has been developed for the estimation of Tranexamic acid in bulk and pharmaceutical dosage formulations. The developed method is based on the formation of condensation product of drug with ferric chloride and potassium ferricynide, which shows absorbance maximum at 710 nm. The proposed method showed linearity in the range of 2-20 ug/ml. Results were statistically validated and were found to be reproducible. Recovery studies indicate that the method is accurate.

 

KEYWORDS:  Tranexamic acid, Ferric chloride, Potassium Ferricynide, Spectrophotometric method

 

 

INTRODUCTION:

Chemically Tranexamic acid is Cis-4(amino methyl) cyclohexane carboxylic acid .TX is used in treatment of mennorhegia and fibrinolysis.

 

Literature survey reveals that only few analytical methods such as UV spectrophotometry5-7, HPLC for estimation of TX. TX Contains amino functional group when present in macro quantities, amino group can be determined by conversion of amino group with ferric chloride and potassium with formation of violet colour complex. The reagent itself produces slight yellow colour. Measurement of absorption of violet solution at λmax 710.0 nm provides the basis for the present developed method.

 

MATERIALS AND METHODS:

Spectral and absorbance measurements were made on Jasco UV/Visible spectrophotometer model V-630. A 0.2% ferric chloride and 0.2% potassium ferricynide were prepared in water and 0.1M H2SO4 was also prepared. These three reagents were used for color development.

 

Standard preparation:

A 100 ug/ml of TX working standard solution was prepared in methanol

 

Sample solution:

About 100 mg of bulk drug or formulation (tablet powder) equivalent to 100 mg of pure drug was used for sample preparation and the drug was extracted using methanol.

 

Procedure:

Accurately pipetted 1ml of working standard solution of TX into 10ml standard flask. The volume was adjusted to 3 ml by adding water.  Then 2ml each of 0.2% w/v Fecl3 and K3Fe(CN) 6 was added and allowed to stand for 5 min.  Finally 1ml of 1 M H2SO4 was added and volume was made up using water. Mixed well. Absorbances were measured at 710 nm against reagent blank. The amount of TX present in given sample solution was calculated from calibration curve.

 

RESULT AND DISCUSSION:

The optical characteristics and validation parameters were summarized in Table 1.Recovery of the proposed method was found to be 99.87(±0.51) to 100.48(±0.46). Interference studies revealed that the excipient present in dosage form does not interfere in the proposed method.

 

The results that the proposed method is simple, economic, accurate, sensitive and reproducible and can be used for routine analysis of TX in bulk and pharmaceutical dosage forms.

 

Table –1 Optical characteristics and validation parameters of TX

λ max (nm)

710.0

Beer’s law (ug/mL)

2-20

Sandells sensitivity

9.06

Molar absorptivity

(Litre/mole-1/cm-1)

6.0622

 

%RSD

%RSD1

%RSD2

 

 

1.625

1.788

Correlation coefficient

0.9992

 

Regression equation (Y)

Slope (a)

Intercept (b)

 

 

0.0241

0.0053

Y=b+ax Where ‘x’is the concentration of TX in ug/ml and ‘y’ is the absorbance value.

 

ACKNOWLEDGEMENT

The author is thankful to Blue Cross laboratories, Nashik for providing the gift samples of Tranexamic acid,  Principal  MES  College of pharmacy and Mula Education  Society  for providing the necessary facilities.

 

REFERENCES:

1.        Martindale, The extra pharmacopoeia 26th edition The Royal Pharmaceutical Society, London 1989,. 55 and 760.

2.        Indian Pharmacopoeia., Government of India. Ministry of Health and Family Welfare, Published by the Controller of publications,. Delhi. Vol. II.1996; 459.

3.        Shrenik Gangwal and A.K. Sharma, Indian journal of pharmaceutical science,volume-58,no-5  sept –oct.1996,.356

4.        Niopass: Mamzoridi k.,J.Chromatogr B Biomed appl-1994,656,(2):p447-450.

5.        Dinc E, Yucesov c., Iournal of Pharmaceutical and Biomedical Analysis,vol-28  No-6, 1091-1100(2000).

6.        Beckett A.M. Stenlake.J.B. Practical Pharmaceutical Chemistry Part-2, 4th edition New delhi CBS publisher and distributors 2002 ,275

7.        J.M. Green “A practical guide to analytical method validation” Analytical Chemistry 1996. 68. 305A.

8.        Basvaiah K.Indian drugs .vol-41,No-5, May –2004,303.

 

 

 

Received on  02.05.2009         Modified on 15.06.2009

Accepted on 02.07.2009         © AJRC All right reserved

Asian J. Research Chem.  2(3): July-Sept.  2009 page 273-274