Validação analítica em CLAE-UV para monitoração plasmática da metilprednisolona e do succinato de metilprednisolona

Resumo

The HPLC-UV analytical method validation aimed the quantification of methylprednisolone (MP) and its succinate sodic ester (MPSS) in human plasma of patients with lupus. Triancinolone (500 g/mL) was used as internal standard the standards MP and MPSS were spiked in plasma in the range of 10 and 1.0 g/mL. The chromatographic conditions employed an isocratic mobile phase (acetonitrile:water:acetic acid 47:50:03), flow rate of 0.8 mL/min and a RP18 column (25 cm and 0.4 mm i.d.) coupled to an UV detector set at 254 nm. The parameters of analytical validation are in compliance with international regulations and with the Brazilian sanitary legislation. Beyond excellent linearity (RMP = 0.99933; RMPSS = 0.99638), it showed high intraday and interday precision (< 7%), good accuracy (94,0 ± 2.3%), adequate limit of quantification (0.25 g/mL) and good recovery (> 85%). Additionally, the technique have shown to be robust, steady, selective and can be used in the dosage of methylprednisolone in patients under pulsotherapy and also in situations of acute poisoning and therapeutical monitoring.

Descrição

Palavras-chave

Validação, Técnica analítica, HPLC, Metilprednisolona, Lúpus Eritematoso Sistêmico, Validation, Analytical technique, HPLC-UV, Methylprednisolone, Lupus

Citação

CUNHA, Luiz Carlos da; RAMALHO, Pedro Ivo Sebba; REZENDE, Kênnia Rocha; MARINHO, Carlos H. C.; OLIVEIRA, Emílio Costa de; SILVA, Nílzio Antonio da. Validação analítica em CLAE-UV para monitoração plasmática da metilprednisolona e do succinato de metilprednisolona. Revista Eletrônica de Farmácia, Goiânia, v. 1, n. 1, p. 23-34, jan./dez. 2004. Disponível em: <https://www.revistas.ufg.br/REF/article/view/1759/1850>.