Methylprednisolone Hemisuccinate and Metabolites in Urine from Patients Receiving High-Dose Corticosteroid Therapy

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Abstract
A reversed-phase high-performance liquid chromatographic (RP-HPLC) method for the measurement of methylprednisolone hemisuccinate (MPHS) and its metabolites methylprednisolone (MP), 20-α- (20a-HMP), and 20-β-hydroxymethylprednisolone (20b-HMP) in urine is described. The metabolites were extracted from urine samples using Extrelut columns and eluted with ethylacetate. The mobile phase for RP-HPLC comprised methanol:citrate buffer:tetrahydrofuran (30:65:5, vol/vol/vol) with UV detection at 251 nm. Fractions were collected, pooled and the metabolites present were identified by gas chromatography-mass spectrometry and normal-phase HPLC (NP-HPLC). By RP-HPLC 30 ± 7.3% (mean ± 1 SD) of the dose was detected in the 0–24 h urine sample following a 1 g MPHS infusion to patients with rheumatoid arthritis; MPHS contributed 9.9 ± 5.0%, MP 12.1 ± 2.9%, 20a-HMP 7.8 ± 2.2%, and 20b-HMP 1.0 ± 0.3%, respectively. A further 1.0 ± 0.9% of the administered dose was detected in urine collected 24–48 h postinfusion.

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