UV SPECTROPHOTOMETRIC ASSAY METHOD DEVELOPMENT AND VALIDATION OF DABIGATRAN ETEXILATE IN CAPSULES

  • Syed Shahed Hussain Jawaharlal Nehru technological University, Hyderabad (JNTUH)
  • G. Bhavani Jawaharlal Nehru technological University, Hyderabad (JNTUH)
  • A. Ashok Kumar Department of Pharmaceutical Analysis and Quality Assurance, Vijaya College of Pharmacy, Munaganur (village), Hayathnagar (mandal), Hyderabad 501511, India

Abstract

Objective: To develop a simple and a cheap UV spectrophotometric method for the quantitative estimation of Dabigatran etexilate in capsules and validate as per ICH guidelines.

Methods: The optimized method uses triethyl ammonium phosphate aqueous solution (pH 2.5) as a solvent for the estimation of assay of Dabigatran etexilate in capsules at a wavelength of 325 nm.

Results: The developed method resulted in Dabigatran etexilate exhibiting linearity in the range 5-15μg/ml. The assay precision is exemplified by relative standard deviation of 1.07%. Percentage Mean recovery was found to be in the range of 98â€102, during accuracy studies. Method was found to be robust with respect to wavelength and pH of the solvent.

Conclusion: A simple and a cheap UV spectrophotometric method was developed and validated for the quantitative estimation of Dabigatran etexilate in capsules as per ICH guidelines and hence it can be used for routine analysis in various pharmaceutical industries.

 

Keywords: UV, Dabigatran etexilate, Method development, Validation

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Author Biographies

Syed Shahed Hussain, Jawaharlal Nehru technological University, Hyderabad (JNTUH)
M.Pharmacy student, Department of Pharmaceutical Analysis and Quality assurance
G. Bhavani, Jawaharlal Nehru technological University, Hyderabad (JNTUH)
M.Pharmacy student, Department of Pharmaceutical Analysis and Quality assurance
A. Ashok Kumar, Department of Pharmaceutical Analysis and Quality Assurance, Vijaya College of Pharmacy, Munaganur (village), Hayathnagar (mandal), Hyderabad 501511, India

Professor and Head of the department of Pharmaceutical Analysis and Quality assurance

 

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How to Cite
Hussain, S. S., G. Bhavani, and A. A. Kumar. “UV SPECTROPHOTOMETRIC ASSAY METHOD DEVELOPMENT AND VALIDATION OF DABIGATRAN ETEXILATE IN CAPSULES”. International Journal of Pharmacy and Pharmaceutical Sciences, Vol. 8, no. 8, June 2015, pp. 286-9, https://innovareacademics.in/journals/index.php/ijpps/article/view/6401.
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