Validación de un método de cromatografía líquida para la determinación de rifampicina en plasma humano

Luis Moreno-Exebio; Miguel Grande-Ortiz

doi:10.17843/rpmesp.2014.311.8

Authors

Luis Moreno-Exebio Centro Nacional de Control de Calidad, Instituto Nacional de Salud. Lima, Perú. Químico Farmacéutico
Miguel Grande-Ortiz Centro Nacional de Control de Calidad, Instituto Nacional de Salud. Lima, Perú. Químico Farmacéutico

DOI:

https://doi.org/10.17843/rpmesp.2014.311.8

Keywords:

Chromatography, high pressure liquid, Validation studies, Rifampin

Abstract

Objectives. To validate the high-performance liquid chromatography method (HPLC) for rifampicin (RFP) determination in human plasma. Materials and methods. A HPLC method for RFP determination in plasma was developed. The separation was performed by reversed-phase chromatography with C18 column and a mobile phase composed of a mixture of acetonitrile and monobasic potassium phosphate buffer solution 0.05 M (38:62 v/v) at 335 nm in which standard rifampicin quinone (RFP-QN) was used. Results. The retention times of RFP and RFP-QN were 7.81 and 12.26 minutes, respectively. The trial was linear from 0.5 to 250 ug/mL. The evaluated parameters of precision, accuracy, selectivity, linearity, and recovery complied with the established international standards for validation of bioanalytical methods. Conclusions. The developed HPLC method is simple, specific, sensitive, selective and linear for a wide range of RFP concentrations in plasma.