Research Journal of Pharmacy and Technology
SCOPUS
  • Year: 2025
  • Volume: 18
  • Issue: 5

A new stability indicating RP-HPLC method for the estimation of Luliconazole in presence of internal standard

GITAM School of Pharmacy, GITAM University, Visakhapatnam, India-530045

*Corresponding Author E-mail: mmukthin@gitam.edu

Online Published on 29 July, 2025.

Abstract

Luliconazole is an antifungal drug used for treating the skin infections. A new stability indicating RP-HPLC method has been developed for the estimation of Luliconazole in presence of internal standard using Zorbox C8 column (150 mm × 4.60 mm i. d. 5µm particle size) with PDA detector in pharmaceutical dosage forms. A mixture of acetonitrile, methanol and phosphate buffer (pH 4.5) was used for the chromatographic separation with a flow rate of 0.8 mL/min. and UV detection at 245 nm. Linearity was observed over the concentration range of 0.5-100 μg/mL with linear regression equation y = 0.0215x - 0.0018 (R2 = 0.9999). Forced degradation studies were performed and the method was validated as per ICH guidelines. The LOD and LOQ were found to be 0.1321 μg/mL and 0.4082 μg/mL respectively. The method was validated and found to be precise, accurate and robust.

Keywords

Luliconazole, Stress degradation studies, ICH guidelines, Validation