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 25oC 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.