Simultaneous determination of triacetin, acetic ether, butyl acetate and amorolfine hydrochloride in amorolfine liniment by HPLC

ABSTRACT

A simple, rapid, specific and precise reversed-phase high-performance liquid chromatographic method was developed for simultaneous estimation of triacetin, acetic ether, butyl acetate and amorolfine in marketed pharmaceutical liniment. Chromatographic separation was performed on a Shimadzu VP-ODS C18 column using the mixture of citric acid-hydrochloric acid-sodium hydrate buffer [pH 3.0], acetonitrile and methanol [323038] as the mobile phase at a flow rate of 1.0 mL/min with UV-detection at 215 nm. The method separated the four components simultaneously in less than 10 min. The validation of the method was performed with respect to specificity, linearity, accuracy, and precision. The calibration curves were linear in the range of 35.1-81.9 micro g/mL for triacetin, 431.1-1005.9 micro g/mL for acetic ether, 167.0-389.7 micro g/mL for butyl acetate and 151.0-352.3 micro g/mL for amorolfine. The mean 100% spiked recovery for triacetin, acetic ether, butyl acetate and amorolfine is 99.43 +/- 0.42, 101.5 +/- 1.09, 101.4 +/- 1.02 and 100.8 +/- 0.69, respectively. The intra-day and inter-day relative standard deviation values were <2.0%. The limits of detection of these compounds ranged from 0.08 to 5.88 ng. The utility of the procedure was verified by its application to the commercial liniment