Development and Validation of Stability Indicating RP-HPLC Method for Estimation of Voriconazole in Bulk Drug

DOI:

https://doi.org/10.37285/ijpsn.2010.3.2.11

Authors

  • Wamorkar V V
  • C S Ramaa
  • Manjunath S Y
  • V Malla Reddy

Abstract

RP-HPLC method has been developed and validated for the determination of voricaonazole in bulk drug. The developed method is found to be specific, reproducible, and stability indicating. The Hypersil, C18 (250 X 4.6 mm) 5μ column was used and mobile phase consisting of water:acetonitrile to achieve good resolution and retention of the analyte and its impurities. The detector linearity was established from concentrations ranging from 5-100 μg/ml. The method was tested at different levels of specificity and accuracy as per requirements given in ICH guidelines. The molecule was exposed to the stress conditions such as acid, base, oxidation, heat and light as per the recommendations of ICH guidelines. The method was proved to be robust with respect to changes in flow rate, mobile phase composition and allied columns. The proposed method is found to be sensitive, precise, rapid, reproducible, and offers good column life.

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Keywords:

Voriconazole, HPLC method, Validation, Stability indicating, ICH guidelines

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Published

2010-08-31

How to Cite

1.
V V W, Ramaa CS, S Y M, Reddy VM. Development and Validation of Stability Indicating RP-HPLC Method for Estimation of Voriconazole in Bulk Drug. Scopus Indexed [Internet]. 2010 Aug. 31 [cited 2024 May 10];3(2):978-86. Available from: https://www.ijpsnonline.com/index.php/ijpsn/article/view/504

Issue

Vol. 3 No. 2 (2010): July-September 2010

Section

Research Articles
Crossref
Scopus
Google Scholar
Europe PMC

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