Method for pretreatment and method for analysis of lenalidomide in biological sample
The present invention addresses the problem of providing a novel method for the pretreatment of a biological sample containing lenalidomide enantiomer and thereby establishing a simple and accurate method for the quantitative analysis of lenalidomide enantiomer. In the present invention, the racemization and decomposition of lenalidomide enantiomer in a biological sample can be prevented by the deproteinization under acidic conditions of the biological sample containing lenalidomide enantiomer, and the lenalidomide enantiomer can be simply and accurately quantitatively analyzed by subjecting to HPLC the biological sample that has been pretreated in such a way.
1. A method for quantifying enantiomers of lenalidomide in a biological sample, comprising
pretreating a biological sample containing enantiomers of lenalidomide by deproteinizing the biological sample under acidic conditions to minimize racemization of the enantiomers of lenalidomide relative to a method where a biological sample containing enantiomers of lenalidomide is not deproteinized under acidic conditions; and
separating and quantifying the enantiomers of lenalidomide by high-performance liquid chromatography of the biological sample containing enantiomers of lenalidomide that has been pretreated.
2. The method according to claim 1 , wherein the acidic conditions are pH 5 or lower.
3. The method according to claim 1 , wherein an acid selected from among perchloric acid, trichloroacetic acid, trifluoroacetic acid, metaphosphoric acid, hydrochloric acid, succinic acid and maleic acid is added.
4. The method according to claim 1 , wherein the biological sample is blood, serum, blood plasma, urine, saliva, breast milk, spinal fluid, semen, tissue or microsomes.
5. The method according to claim 1 , wherein the enantiomer of lenalidomide is the S-form.
6. The method according to claim 1 , wherein the enantiomer of lenalidomide is the R-form.