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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.

Abstract

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.

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Keywords

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

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