Approaches to Development of Analytical Method for Combination Products Containing Fluconazole

Abstract

Fluconazole is a commonly used antifungal agent. It is marketed as solid oral dosage forms, intravenous preparations as well as combination products along with other antimicrobial agents. Pharmacopoeial analytical methods are available for fluconazole tablets and capsules. However, there are no official methods for analysis of fluconazole in combination products. As a result, in house analytical method has to be developed and validated for such products. The main objective of this article is to identify possible approaches towards the analytical method development for combination products containing fluconazole. For this research papers from various journals were compared with respect to its objectives, methods parameters and results. For fluconazole combination products, an analytical method based on Ultra violet (UV) spectrometry may not be as well suited as a method based on high pressure liquid chromatography (HPLC). In areverse phase (RP) HPLC based method, a mobile phase consisting of water and an organic solvent like methanol and acetonitrile in 60:40 v/v or 80:20 v/v could be used. For a non ionic compound like fluconazole a neutral pH buffer should be preferred to enhance resolution. pH of the buffer should only be changed to increase retention time in favour of another drug which eludes faster. A mobile phase of methanol: neutral buffer in 50:50 v/v may help to produce the lowest retention time. These approaches can lead to a validated and accurate analytical method for fluconazole containing combination products.