Research in Pharmaceutical Biotechnology
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Article Number - EEE1CE2453


Vol.2(1), pp. 001-006 , February 2010

ISSN: 2141-2324


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Full Length Research Paper

Validation and stability indicating RP-HPLC method for the determination of tadalafil API in pharmaceutical formulations



B. Prasanna Reddy
  • B. Prasanna Reddy
  • Department of Quality control, Nosch Labs Pvt Ltd, Hyderabad-500072, A.P, India.
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K. Amarnadh Reddy
  • K. Amarnadh Reddy
  • Department of AR and D, Aurigene Discovery Technologies Ltd, Bangalore, India.
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M. S. Reddy
  • M. S. Reddy
  • Department of Plant Pathology and Entomology, Auburn University, USA.
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 Accepted: 04 January 2010  Published: 28 February 2010

Copyright © 2010 Author(s) retain the copyright of this article.
This article is published under the terms of the Creative Commons Attribution License 4.0


 

The present study describes the development and subsequent of a stability indicating RP-HPLC method for the analysis of tadalafil. The samples separated on an Inertsil C18, (5 m , 150 mm x 4.6 mm i.d) by isocratic run using acetonitrile and phosphate buffer as mobile phase), with a flow rate of 0.8 ml/min, and the determination wavelength was 260 nm for analysis of tadalafil. The described method was linear within range of 70 - 130 µg/ml (r2 = 0.999). The precision, ruggedness and robustness values were also within the prescribed limits (< 1% for system precision and < 2% for other parameters). Tadalafil was exposed to acidic, basic, oxidative and thermal stress conditions and the stressed samples were analyzed by the proposed method. Chromatographic peak purity results indicated the absence of co-eluting peaks with the main peak of tadalafil, which demonstrated the specificity of assay method for estimation of tadalafil in presence of degradation products. The proposed method can be used for routine analysis of tadalafil in quality control laboratories.

 

Key words: RP-HPLC, tadalafil, validation, stability indicating assay, forced degradation.


APA (2010). Validation and stability indicating RP-HPLC method for the determination of tadalafil API in pharmaceutical formulations. Research in Pharmaceutical Biotechnology, 2(1), 001-006.
Chicago B. Prasanna Reddy, K. Amarnadh Reddy and M. S. Reddy. "Validation and stability indicating RP-HPLC method for the determination of tadalafil API in pharmaceutical formulations." Research in Pharmaceutical Biotechnology 2, no. 1 (2010): 001-006.
MLA B. Prasanna Reddy, K. Amarnadh Reddy and M. S. Reddy. "Validation and stability indicating RP-HPLC method for the determination of tadalafil API in pharmaceutical formulations." Research in Pharmaceutical Biotechnology 2.1 (2010): 001-006.
   
DOI https://doi.org/
URL http://academicjournals.org/journal/RPB/article-abstract/EEE1CE2453

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