Development and Validation of RP-

HPLC Method for the Estimation of

Oxiconazole Nitrate in Bulk and
Pharmaceutical Dosage Form.

By: Kalpana Gaikwad

 Content
• Introduction
• Objective
• Plan of Work
• References
 Introduction
• Analytical method plays an important role in the discovery, development and
manufacturing of pharmaceuticals. The aim of method development is to develop
analytical method for drug product containing active ingredient to allow accurate and
precise quantitation of drug 1, 2.
• The objective of the analytical procedure should be clearly understood since this will
govern the validation characteristics which need to be evaluated. Typical validation
characteristics which should be considered are listed below[3]:
Accuracy
Precision
• Repeatability
• Intermediate Precision
Specificity
Detection Limit
Quantitation Limit
Linearity
Range
 Oxiconazole Nitrate
• Oxiconazole Nitrate is the nitrate salt form of oxiconazole, a broad spectrum
imidazole derivative with antifungal activity.
• Although the exact mechanism of action has yet to be fully elucidated, oxiconazole,
like other azole antifungals, most likely inhibits the cytochrome P450-dependent
demethylation of lanosterol.
• This prevents the synthesis of ergosterol which is a crucial component of fungal
cell membrane.
• By disrupting fungal cell membrane synthesis and integrity, oxiconazole alters
fungal cell membrane permeability, promotes loss of essential intracellular
components and eventually inhibits fungal cell growth.
• Its molecular formula is C18H14Cl4N4O4, and its molecular weight is 492.1
g/mol. [4]
Structure of Oxiconazole Nitrate
• (E)-1-(2,4-dichlorophenyl)-N-[(2,4-dichlorophenyl)methoxy]-2-imidazol-
1ylethanimine; nitric acid is the chemical name for Oxiconazole Nitrate. It
is white to off-white powder. It is soluble in acetonitrile, di methyl
formamide, di methyl sulphoxide and practically insoluble in water. It is an
antifungal agent.[4]
• In literature review, not many methods are available for determination of
Oxiconazole Nitrate by RP- HPLC. [5] The present work, is therefore
focused on to achieve the optimum chromatographic conditions for the
determination of Oxiconazole Nitrate in a formulation by RP-HPLC
method, And validate according to ICH guidelines.
 Objective
• To develop and validate RP-HPLC method for
estimation of Oxiconazole Nitrate in bulk & dosage
form.
 Plan of Work
• Review of literatures.
• Procurement of active pharmaceutical ingredient,
dosage form, chemicals, and solvents, etc.
• Development of analytical method, for estimation of
Oxiconazole Nitrate in bulk and dosage form.
• Validation of method as per ICH guidelines.
• Dissertation writing/publication.
 References
1. Analytical Method Development [Internet]. [cited 2020 Aug 8].
Available from:
http://shodhganga.inflibnet.ac.in/bitstream/10603/8513/9/09_chapter%20
2.pdf
2. Aim and objective [Internet]. [cited 2020 Aug 8]. Available from:
http://shodhganga.inflibnet.ac.in/bitstream/10603/54485/5/chapter%202.
pdf
3. Validation of Analytical Procedures: Text and Methodology; Guidline
Q2(R1); International Conference on Harmonisation(ICH);November
2005; Page No. 1-13.
4. Oxiconazole Nitrate [Internet]. Pubchem. [Last accessed on 13-06-2021].
Available From: https://pubchem.ncbi.nlm.nih.gov/compound/Oxistat
5. Milano, Julie & Muller Morsch, Lisoni & Cardoso, Simone. LC method
for the analysis of Oxiconazole in pharmaceutical formulations. Journal
of pharmaceutical and biomedical analysis. 2002; 30: 175-80.