Abstract

STABILITY-INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF LULICONAZOLE AND SALICYLIC ACID IN ITS TOPICAL DOSAGE FORM

Manisha Kotadiya*, Riya Dasadiya

Abstract

A simple, rapid, precise, and stability-indicating RP-HPLC method was developed and validated for the simultaneous estimation of Luliconazole and Salicylic Acid in pharmaceutical dosage form. Separation was achieved on a YMC Pack ODS-A column (150 mm × 4.6 mm, 5 μm) using Buffer: Methanol (30:70 % v/v) as mobile phase at a flow rate of 1.0 mL/min, with detection at 226 nm. The method showed excellent linearity in the range of 10–30 μg/mL for Luliconazole and 30–90 μg/mL for Salicylic Acid (R² > 0.998). Accuracy studies showed recoveries of 98% and 99.6%, respectively. LOD and LOQ values indicated good sensitivity. Forced degradation studies under various stress conditions confirmed the stability-indicating nature of the method, with clear separation of degradation products. The method is suitable for routine quality control analysis.

Keywords: Luliconazole; Salicylic Acid; RP-HPLC; Stability-indicating method; Method validation; Forced degradation; Pharmaceutical dosage form; Linearity; Accuracy; Precision; LOD; LOQ.