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Research Journal of Pharmacy and Technology
Year : 2016, Volume : 9, Issue : 12
First page : ( 2234) Last page : ( 2240)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2016.00451.0

A novel method development and validation for related substances of adapalene in bulk drug product by HPLC

Kumar G.1, Patrudu T B.2,*, Rao M.V. Basaveswara1, Rao Tentu. Nageswara1

1Department of Chemistry, Krishna University, Machilipatnam, Andhra Pradesh, India

2Department of Chemistry, GITAM University, Hyderabad Campus, Telangana, India

*Corresponding Author E-mail: tnraochemistry@gmail.com

Online published on 2 March, 2017.


A simple and inexpensive method was developed with high performance liquid chromatography with PDA detection for determination of Adapalene and related impurities ((3-Adamantyl-4-methoxy) phenyl boronic acid, 6-(toluene-4-sulfonyloxy)-naphtalene-2-carboxylic acid methyl ester, 1-adamantyl-2-methoxybenzene, 6-(3-adamantan-1-yl-4-methoxy-phenyl)-naphtalene-2-carboxylic acid methyl ester and 3, 3’-di-(1-adamantyl)-4, 4’-dimethoxy-1, 1’-biphenyl). The chromatographic separations were achieved on (250×4.6 mm), 5.0 μm make: Phenomenex Luna column employing methanol, 0.1% orthophosphoric acid buffer, and Tetrahydrofuran in the ratio of 55: 30: 15 as mobile phase with gradient programmed at flow rate 1.0 mL/min was chosen. Five impurities were eluted within 35 minutes. The column temperature was maintained at 25°C and a detector wavelength of 260 nm was employed. The method was successfully validated by establishing System Suitability, Specificity, Linearity, Accuracy, limit of detection and Limit of quantification.



HPLC, Method validation, related impurities, Adapalene, LOQ, LOD.


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