Reversed phase high-performance liquid chromatography for the evaluation of Luliconazole in bulk and pharmaceutical preparations
DOI:
https://doi.org/10.12923/cipms-2025-0012Keywords:
cream, luliconazole, method development, RP-HPLC, validationAbstract
A new precise economical RP-HPLC analytical approach will serve as the basis for Luliconazole assay determination – both in bulk drug form and topical cream format. The separation took place on a HPLC device. The chromatographic separation was performed on a reverse-phase C-18 column (250 mm × 4.6 mm, 5 µ) using 0.1% OPA: acetonitrile (75:25) as the mobile phase at a flow rate of 1.10 mL/min. The wavelength of 298 nm was employed for detecting the effluents through the system. The physical measurement revealed that Luliconazole exists at 3.112 minutes, and the determined correlation coefficient value for Luliconazole measurement reached 0.996, while Luliconazole measurement in the formulation range from 98% to 102%. The study validated the Luliconazole (LOD) and limit of quantification (LOQ) values of 1.31 µg/mL and 3.98 µg/mL, respectively. Its simplicity, accuracy, rapid execution and ease of implementation revealed a successful application of method for the analysis of Luliconazole in bulk drug and topical cream formulations.
References
1. Khanna D, Bharti S. Luliconazole for the treatment of fungal infections: an evidence-based review. Core Evid. 2014;9:113-24.
2. Alhakamy NA, Shadab MD, Alam S, Shaik RA, Ahmad J, Ahmad A, et al. Development, optimization, and evaluation of Luliconazole nanoemulgel for the treatment of fungal infection. J Chem. 2021;1:1-17.
3. Khare AS, Ansari AM, Patil RY, Paki PR, Ingale SS, Perampalli NL. Design and development of Luliconazole and curcumin loaded nanoemulsion for the treatment of fungal wound infection. Int J Recent Sci Res. 2021;12(07):42178-83.
4. Sultan, MA, El-Alamin MMA, Atia MA, Aboul-Enein HY. Stability-indicating methods for the determination of Luliconazole by TLC and HPTLC-densitometry in bulk powder and cream dosage form. JPC J Planar Chromat. 2017;30:68-74
5. Malasiya A, Goyal A. Method development and validation of RP HPLC method for assay and related substances of luliconazole in topical dosage form. Int J Pharm Chem Analysis. 2017;4(2):46-50
6. Majumder T, Razibul H, Pritam R, Ratan P, Nazmul H. Method development and validation of RP-HPLC method for estimation of luliconazole in marketed formulation (Cream). Pharma Innov J. 2019;85:103-8.
7. Paladugu VN, Seru G. Development and validation of a new stability indicating ultra-fast liquid chromatographic (RP-UFLC) method for the quantification of luliconazole. AS PS. 2021;5(10):21-8.
8. Bavand Savadkouhi M, Vahidi H, Ayatollahi AM, Hooshfar S, Kobarfard F. RP-HPLC method development and validation for determination of eptifibatide acetate in bulk drug substance and pharmaceutical dosage forms. Iran J Pharm Res. 2017;16(2):490-7.
9. Dongala T, Katakam LNR, Palakurthi AK, Katari NK. RP-HPLC Stability indicating method development and validation of pseudoephedrine sulfate and related organic impurities in tablet dosage forms, robustness by QbD approach. Anal Chem Lett. 2019;9(5):697-710.
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