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.

Downloads

Download data is not yet available.

Metrics

Metrics Loading ...

Keywords:

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

Downloads

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 Nov. 22];3(2):978-86. Available from: https://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

References

Bakshi M, Singh S. The ICH guidelines in practice: stress degradation studies on Ornidazole and development of validated stability indicating assay. J. of Pharm. and Biomed. Ana. 26 (2001) pp 891-897.

Hitchcock5 C, et al.UK-109,496. A novel, wide spectrum triazole derivative for treatment of fungal infection: antifungal activity and selectivity in vitro (abstract F76). Presented at 35th Intersciences Conferences on Antimicrobial Agents and Chemotherapy, Toronto, Canada, sept 28-Oct 1, 1995.

ICH guidelines Q2B Validation of Analytical Procedures: Methodology International Conference on Harmonisation of Technical requirements for registration of Pharmaceuticals for Human use, Geneva, Swizterland, 1996.

ICH guidelines Q3A and Q3B ICH Harmonized Tripartite guideline: Impurities in new drug substance and drug products 2004.

ICH stability testing of new drug substance and product in: proceeding of the international conference on Harmonization, IFPMA. Geneva. 2000

International Conference on Harmonization Steering Committee. Q1A - Stability Testing of New Drug Substance and Products, 1999.

Patterson BE, Coates PE.1995.UK-109, 496, A novel wide spectrum triazole derivative for treatment of fungal infection; pharmacokinetics in man ,abstr.F78,p-126.In human program and abstract of the 35th Intersciences Conferences on Antimicrobial Agents and Chemotherapy. American society for microbiology, Washington, D.C.

Wellington M, Gigliotti F. Update on antifungal agents .Pediatric Infections Diseases J, 2001; 20; pp 993-996.

Winfield J., R.M.E.Richards, “Storage and stability of medicine”, Pharmaceutical Practice, 2nd edition, pp 83, 1998.