Rapid and Selective UV Spectrophotometric and RP-HPLC Methods for Dissolution Studies of Ivabradine Controlled-Release Formulations

  • Posted on: 1 August 2014
  • By: admin

 

 

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PharmaTutor (August- 2014)
ISSN: 2347 - 7881
(Volume 2, Issue 8)

 

Received On: 06/06/2014; Accepted On: 08/06/2014; Published On: 01/08/2014

 

AUTHORS: Sagarika Panda1*, Srikanta Patra2
1 Jawaharlal Nehru Technological University Hyderabad, Kukatpally, Hyderabad, Andhra Pradesh, India;
2 National Institute of Pharmaceutical Education & Research (NIPER), Ahmedabad, Gujarat, India
*niperhsagarika@gmail.com

 

ABSTRACT:
A highly sensitive, selective, reproducible, rapid and stability indicating RP-HPLC and spectrophotometric method has been developed and validated successfully for quantitative evaluation of ivabradine hydrochloride formulations. Chromatography was carried out at 25ºC on a 250 mm x 4.6 mm, 5µm, C18,  100Aº Kromasil column with phosphate buffer pH 7.4: methanol:: 35:65 and U.V. detector at λmax 286 nm. In HPLC method the retention time was about 7.4 minutes. Complete validation study for both the methods was carried out according to ICH guideline. Both methods were found to be selective, linear, accurate and precise in the specified ranges. Linearity of both the methods was achieved in the range 5 to 60 μg/ml with a correlation coefficient (r2) ≥ 0.999. The LOD and LOQ of HPLC method were 0.05 and 0.2 µg/ml, respectively. Intra-day and inter-day variability for both methods were <2% RSD. These methods were successfully used for quantification of ivabradine in drug-release studies from immediate-release tablets and controlled-release (CR) formulations.

 

How to cite this article: S Panda, S Patra; Rapid and Selective UV Spectrophotometric and RP-HPLC Methods for Dissolution Studies of Ivabradine Controlled-Release Formulations; PharmaTutor; 2014; 2(8); 201-213

 

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