Research Article
Formulation and Development of a Water-in-Oil Emulsion-Based
Luliconazole Cream: In Vitro Characterization and Analytical
Method Validation by RP-HPLC
Vijay Kumar Panthi
1,2,3,4
and Utsav Nepal
5,6
1
Department of Pharmacy, Tribhuvan University, Sunsari Technical College, Sunsari, Nepal
2
Research & Development Department, Royal Sasa Nepal Pharmaceuticals, Chitwan, Nepal
3
Research & Development Department, Asian Pharmaceuticals, Rupandehi, Nepal
4
Research & Development Department, Corel Pharmaceuticals, Rupandehi, Nepal
5
Department of Pharmacy, Kathmandu University, School of Science, Dhulikhel, Nepal
6
Quality Control Department, Royal Sasa Nepal Pharmaceuticals, Chitwan, Nepal
Correspondence should be addressed to Vijay Kumar Panthi; nepalivijay7@gmail.com
Received 5 July 2022; Revised 5 August 2022; Accepted 10 August 2022; Published 23 September 2022
Academic Editor: Suresh Ponnayyan Sulochana
Copyright © 2022 Vijay Kumar Panthi and Utsav Nepal. is is an open access article distributed under the Creative Commons
Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is
properly cited.
Luliconazole (LCZ) is a new antifungal agent containing imidazole moiety which revealed broad-spectrum antifungal activity. e
aim of this research was to prepare water-in-oil (w/o) emulsion-based cream formulation of LCZ in addition to the development
and validation of an analytical method by reverse-phase high-performance liquid chromatography (RP-HPLC). Cetostearyl
alcohol (12.14%), light liquid paraffin (5.00%), white soft paraffin (2.75%), and Tween-80 (1.00%) appeared as the optimized
concentration to give better consistency to the cream. Moreover, without adding pH adjusting agents the pH of the optimized
formulation (F5) was obtained within the range of human skin pH throughout the stability period. e value of particle size,
polydispersity index, and zeta potential was 187.90 ± 2.061 nm, 0.124 ± 0.026, and -10.553 ± 1.349 mV, respectively. In this study,
an analytical C18 (4.6 mm × 25 cm), 5 μm column was used for chromatographic separation with a mixture of acetonitrile and
water in the proportion of 50 : 50 v/v as the mobile phase at a flow rate of 1.0 mL/min. e calibration curve was obtained linear at
296 nm in the concentration range of 0.08–0.12 mg/mL. Furthermore, the limit of detection (LOD) and limit of quantification
(LOQ) were 0.0013 and 0.0042 µg/mL, respectively. In addition, the observed results demonstrated that our developed method was
linear (R2 = 0.999), precise (%RSD below than 2.0%), and accurate (mean recovery% = 100.18–100.91). e F5 showed no physical
changes until 6th month analysis at room temperature and accelerated conditions. Similarly, the assay obtained 101.99% ± 0.27
and 99.89% ± 0.08 at room temperature and accelerated conditions, respectively. Additionally, all validated parameters were
obtained within the acceptable limit as well. ese findings conclude that both physically and chemically stable w/o cream
formulation of LCZ can be formulated and assessed for their stability by applying the authenticated analytical procedure of RP-
HPLC.
1. Introduction
Luliconazole (LCZ) is a new antifungal agent consisting of
imidazole moiety with a broad range of antifungal properties
that is structurally associated with its predecessor, lan-
oconazole [1]. e LCZ has demonstrated its broad range of
potentiality against various fungal infections including
dermatophytes and onychomycosis [2]. However, the
mechanism of its antifungal efficacy is still unclear. e
previously published research has reported that this new
drug reveals its action by impeding the fungal cytochrome
P450; that is, 14-α dimethyl enzyme thus inhibits the bio-
synthesis of ergosterol from lanosterol and then finally
hinders the cell wall synthesis within the fungi [3, 4].
Hindawi
International Journal of Analytical Chemistry
Volume 2022, Article ID 7273840, 12 pages
https://doi.org/10.1155/2022/7273840