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. Top Keywords HPLC, Method validation, related impurities, Adapalene, LOQ, LOD. Top |