- Visibility 233 Views
- Downloads 55 Downloads
Method Development and Validation of RP HPLC Method for Assay and related Substances of Luliconazole in Topical Dosage form
- Author Details:
-
Aditi Malasiya
-
Anju Goyal
A simple, specific, accurate, precise , rapid, robust and selective stability indicating reverse phase high performance liquid chromatography (RP-HPLC) method has been developed for assay and related substances and validated for quantification of antifungal drug with its excipients in its topical dosage form. Forced degradation study is done to determine stability of the product. The mobile phase has been used for separation consisting of ammonium acetate buffer: ACN (60:40). Column used was inertsil ODS 3V (4.6*150 mm, 5µm) with flow rate of 1.0 ml/min. Detection wavelength for luliconazole was 294 nm and for methyl paraben was 254nm. The method has been linear for both compounds at 50-150% range with r2 0.998 and 0.999 respectively. Luliconazole and methyl paraben has showed 98-102% recovery. The method have been robust under various variation with flow rate, detection wavelength and column oven temperature. The drug was exposed to stress conditions. Method resolves all degraded product as compared to luliconazole. Developed method can be used routinely for estimation of drug luliconzole with its excipient methyl paraben in dosage form and stability sample.
Keywords: Luliconazole, Methyl paraben, RP-HPLC, Stability, Antifungal, Forced degradation
References
- Khanna D, Bharti S. Luliconazole for the treatment of fungal infections: an evidence-based review. Core Evid. 2014; 9:113-24. [PubMed 25285056]
- Medicis. Luzu (luliconazole) cream 1% prescribing information. Bridgewater, PA: 2013 Nov.
- TanthanaChanapa, BoonleangJustima “Simultaneous stability indicating method for determination of cisapride, methyl paraben, propyl paraben in oral suspension”, Songklankarin Journal of Science and technology. Jul/Aug2010, vol.32 issue 4, p379-385. 7p.
- Leahy M.K, Gesier L, Wang, Morton K, Nakamura N, Wolter M, “ Development of an LC-MS/MS method for the determination of the luliconazole in human toenails”, Covance laboratories Inc., Madison, WI; Topica Pharmaceuticals, Inc, Los Altos, CA
- Sonawane Sandeep, Gide Paraag “Application of experimental design for the optimization of forced degradation and development of a validated stability- indicating LC method for luliconazole bulk and cream formulation”, Arabian Journal of Chemistry, available online 25 March’ 2012.
- FDA guideline for submitting documentation for stability of human drugs nd biologics. Food and Drug Administration, Rockville;1987.
- ICH Q2 (R1). Validation of Analytical Procedure: Text and Methodology. European Medicines Agency; June
How to Cite This Article
Vancouver
Malasiya A, Goyal A. Method Development and Validation of RP HPLC Method for Assay and related Substances of Luliconazole in Topical Dosage form [Internet]. Int J Pharm Chem Anal. 2017 [cited 2025 Oct 31];4(2):46-50. Available from: https://doi.org/
APA
Malasiya, A., Goyal, A. (2017). Method Development and Validation of RP HPLC Method for Assay and related Substances of Luliconazole in Topical Dosage form. Int J Pharm Chem Anal, 4(2), 46-50. https://doi.org/
MLA
Malasiya, Aditi, Goyal, Anju. "Method Development and Validation of RP HPLC Method for Assay and related Substances of Luliconazole in Topical Dosage form." Int J Pharm Chem Anal, vol. 4, no. 2, 2017, pp. 46-50. https://doi.org/
Chicago
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 Anal 4, no. 2 (2017): 46-50. https://doi.org/