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

Química Nova

Universidade Federal de Minas Gerais, Belo Horizonte¹  Ribeiro, Jóse Antônio de Aquino¹  Silva, Breno de Carvalho e¹  Silva, Gisele Rodrigues¹  Nunan, Elzíria Aguiar¹  Soares, Cristina Duarte Vianna¹  Campos, Lígia Maria Moreira de¹  Pianetti, Gerson Antônio¹ 

关键词: indinavir sulfate;    HPLC;    validation.;   

DOI  :  10.1590/S0100-40422005000100010

学科分类：化学（综合）

来源: Sociedade Brasileira de Quimica

【 摘 要 】

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.

【 授权许可】

Unknown