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

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.

Authors

Publication Details

Journal
Zenodo (CERN European Organization for Nuclear Research)
Published
2026-05-01
DOI
https://doi.org/10.5281/zenodo.19876083
Primary Topic
Analytical Chemistry and Chromatography
Type
article
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article

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

Riya Dasadiya2 Manisha Kotadiya*1
Zenodo (CERN European Organization for Nuclear Research)
Analytical Chemistry and Chromatography
article

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

Riya Dasadiya2 Manisha Kotadiya*1
article en

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.

Zenodo (CERN European Organization for Nuclear Research)
Openalex Percentile: Top 9%
Analytical Chemistry and Chromatography
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