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

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