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

Autor: Breno de Carvalho e Silva, Lígia Maria Moreira de Campos, Elzíria Aguiar Nunan, Cristina Duarte Vianna Soares, Gisele Rodrigues Silva, Jóse Antônio de Aquino Ribeiro, Gerson Antônio Pianetti
Jazyk: English<br />Spanish; Castilian<br />Portuguese
Rok vydání: 2005
Předmět:
Zdroj: Química Nova, Vol 28, Iss 1, Pp 50-53 (2005)
Druh dokumentu: article
ISSN: 0100-4042
1678-7064
DOI: 10.1590/S0100-40422005000100010
Popis: 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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