Development and Validation of a New Stability Indicating Ultra-Fast Liquid Chromatographic (RP-UFLC) Method for the Quantification of Luliconazole
Paladugu Venkata Naveen* and Seru Ganapaty
Department of Pharmaceutical Analysis and Quality Assurance, Gandhi Institute of Technology and Management (Deemed to be University), GITAM Institute of Pharmacy, Visakhapatnam, Andhra Pradesh, India
*Corresponding Author: Paladugu Venkata Naveen, Department of Pharmaceutical Analysis and Quality Assurance, Gandhi Institute of Technology and Management (Deemed to be University), GITAM Institute of Pharmacy, Visakhapatnam, Andhra Pradesh, India.
August 18, 2021; Published: September 06, 2021
Luliconazole is an antifungal agent. A new stability indicating RP-UFLC method has been developed for the estimation of Luliconazole using Shimadzu UFLC system (PDA detector) with Zorbox C8 column (150 mm × 4.60 mm i.d. 5µm particle size) in bulk and pharmaceutical dosage form and validated as per ICH guidelines. A mixture of tetra butyl ammonium hydrogen sulphate and acetonitrile was used for the chromatographic separation with a flow rate of 1 mL/min. and UV detection at 220 nm. Linearity was observed over the concentration range of 0.1-100 μg/mL with linear regression equation y = 89055x - 1545.2 (R2 = 0.9998). Forced degradation studies were performed and Luliconazole was found to be more sensitive towards acidic and oxidation conditions. The LOD and LOQ were found to be 0.0311 and 0.0981. The method was validated and found to be precise, accurate and robust.
Keywords: Luliconazole; Forced Degradation Studies; Validation; ICH Guidelines
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