The Development and validation of few UV Spectrophotometric methods for the determination of Apremilast in bulk form and pharmaceutical dosage form

Abstract

Apremilast is an analog of thalidomide and used as a medication for the treatment of certain type of psoriasis and psoriatic arthritis. It is pale yellow to white colour powder which is non-hygroscopic and practically insoluble in water and buffer solutions of wide pH range, but is soluble is lipophilic solvents like acetone , acetonitrile , butanone , dichloromethane and tetrahydrofuran. Validation study was performed to develop novel, simple, precise, sensitive and accurate UV spectrophotometric method w for the estimation of Apremilast. Double beam UV-VIS spectrophotometer (UV-1800, Shimadzu, Japan) with a pair of 10mm path length matched quartz cells were used for the study. Method A(methanol), Method B(ethanol), Method C(DMSO), Method D( acetonitrile) were developed foe estimation of Apremilast by zero-order and first-order derivative. Linearity was carried out in the concentration range of 0.2-1.0µg/ml and correlation coefficients were found to be 0.999. The relative standard deviation was found to be <2%. The LOD and LOQ were found to be 0.120µg/ml and 0.7810µg/ml respectively. Hence, the methods were validated according to ICH to guidelines and can be adopted for the routine analysis of Apremilast in pure and table dosage form. Keywords: Apremilast, UV visible spectrophotometer, zero-order, first-order derivative, ICH guidelines.