Validation and statistical analysis of two high performance liquid chromatography methods for the determination of indinavir sulfate raw material and capsules

AUTOR(ES)

Silva, Breno de Carvalho e, Campos, Lígia Maria Moreira de, Nunan, Elzíria Aguiar, Soares, Cristina Duarte Vianna, Silva, Gisele Rodrigues, Ribeiro, Jóse Antônio de Aquino, Pianetti, Gerson Antônio

FONTE

Química Nova

DATA DE PUBLICAÇÃO

2005-02

RESUMO

Two high performance liquid chromatography (HPLC) methods for the quantitative determination of indinavir sulfate were tested, validated and statistically compared. Assays were carried out using as mobile phases mixtures of dibutylammonium phosphate buffer pH 6.5 and acetonitrile (55:45) at 1 mL/min or citrate buffer pH 5 and acetonitrile (60:40) at 1 mL/min, an octylsilane column (RP-8) and a UV spectrophotometric detector at 260 nm. Both methods showed good sensitivity, linearity, precision and accuracy. The statistical analysis using the t-student test for the determination of indinavir sulfate raw material and capsules indicated no statistically significant difference between the two methods.

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