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Development and Validation of a Stability-Indicating Rp-Uplc Method for the Determination of Fluconazole in Bulk Drug and in Pharmaceutical Dosage Forms

Fluconazole(FLK) is a synthetic triazole derivative antifungal agent that has been shown to be effective against a wide range of systemic and superficial fungal infections. A simple, cost effective, precise, accurate, and stability-indicating isocratic Ultra Performance Liquid Chromatographic (UPLC) method was developed and validated for the determination of FLK in bulk drug and in its tablets. The use of UPLC, with a rapid 5-minute-reversed-phase isocratic separation on a 1.7 μm reversed-phase packing material to provide rapid “high throughput” support for FLK, is demonstrated. The method was developed using Waters Acquity UPLC BEH C18 column (100 mm× 2.1 mm, 1.7 μm) with mobile phase consisting of a mixture of water and acetonitrile (80:20 v/v). The eluted compound was detected at 210 nm with a UV detector. The standard curve of mean peak area versus concentration showed an excellent linearity over a concentration range 0.3–80 μg.mL−1 FLK with regression coefficient (r2) value of 0.9999. The limit of detection (S/N = 3) was 0.1 μg mL−1 and the limit of quantification (S/N = 10) was 0.3 μg mL−1. Forced degradation of the bulk sample was conducted in accordance with the ICH guidelines. Acidic, basic, hydrolytic, oxidative, thermal, and photolytic degradations were used to assess the stability indicating power of the method. The drug was found to be stable in acidic, basic, thermal, hydrolytic, and photolytic stress conditions and showed slight degradation in oxidative stress condition.