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

Química Nova

Breno De Carvalho E Silva¹  Lígia Maria Moreira De Campos¹  Elzíria Aguiar Nunan¹  Cristina Duarte Vianna Soares¹  Gisele Rodrigues Silva¹  Jóse Antônio De Aquino Ribeiro¹  Gerson Antônio Pianetti¹ 

[1] ,Universidade Federal de Minas Gerais Faculdade de Farmácia Departamento de Produtos FarmacêuticosBelo Horizonte MG

关键词: indinavir sulfate;    HPLC;    validation;   

DOI  :  10.1590/S0100-40422005000100010

来源: SciELO

【 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】

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