Development and validation of RP-HPLC method for simultaneous estimation of luliconazole and beclomethasone dipropionate in topical dosage form

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Original Article

Author Details : Nitin S. Kolhe*, Sameeksha Mhatre, Vaidhun H Bhaskar, Vijaya Kumar, Smita George

Volume : 12, Issue : 1, Year : 2024

Article Page : 46-52

https://doi.org/10.18231/j.jpbs.2024.008

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Abstract

Background: It was found that there was no official method for simultaneous determination of luliconazole and beclomethasone dipropionate.
Aim & Objective: A new, straightforward, reliable, and highly precise HPLC technique for regular quality control analysis of the combination of Luliconazole and Beclomethasone dipropionate in a topical dosage form.
Materials and Methods: For the purpose of separation, 0.1% Glacial acetic acid: Acetonitrile (30:70) was utilised as the mobile phase. Column used was C18 (4.6 X150mm, 5µm) with flow rate of 1.0ml/min. Methanol was used as solvent.
Results: Detection wavelength was 290nm and 242nm, measured at an Rt of 6.6 and 10.2 min. 13 minutes running time, Linearity and range were observed at concentrations from 5µg/ml to 150µg/ml and 0.4µg/ml to 4.8µg/ml of luliconazole and beclomethasone dipropionate respectively. The method developed was linear with a correlation coefficient of 0.999.
Conclusion: Validation of the method was performed according to ICH guidelines for assay, linearity and range, precision, limit of detection, limit of quantitation, and forced degradation test.

Keywords: Simultaneous estimation, Luliconazole, Beclomethasone dipropionate, Validation

How to cite : Kolhe N S, Mhatre S, Bhaskar V H, Kumar V, George S, Development and validation of RP-HPLC method for simultaneous estimation of luliconazole and beclomethasone dipropionate in topical dosage form. J Pharm Biol Sci 2024;12(1):46-52

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