Optimization and validation of high-performance liquid chromatography method for analyzing 25-desacetyl rifampicin in human urine

1st International Conference on Tropical Medicine and Infectious Diseases (ICTROMI) Faculty of Medicine Universitas Sumatera Utara

Lily^1 ; Laila, L.^2 ; Prasetyo, B.E.^2

Master of Biomedical Sciences, Faculty of Medicine, Universitas Sumatera Utara, Medan

20155, Indonesia^1

Department of Pharmaceutical Technology, Faculty of Pharmacy, Universitas Sumatera Utara, Medan

20155, Indonesia^2

关键词: Agilent technologies;    Bioanalytical methods;    Correlation coefficient;    International conference on harmonizations;    Pharmacokinetic analysis;    Relative standard deviations;    Sodium phosphate buffer;    Tuberculosis patients;   

Others  :  https://iopscience.iop.org/article/10.1088/1755-1315/125/1/012221/pdf
DOI  :  10.1088/1755-1315/125/1/012221

来源: IOP

【 摘 要 】

A selective, reproducibility, effective, sensitive, simple and fast High-Performance Liquid Chromatography (HPLC) was developed, optimized and validated to analyze 25-Desacetyl Rifampicin (25-DR) in human urine which is from tuberculosis patient. The separation was performed by HPLC Agilent Technologies with column Agilent Eclipse XDB- Ci8 and amobile phase of 65:35 v/v methanol: 0.01 M sodium phosphate buffer pH 5.2, at 254 nm and flow rate of 0.8ml/min. The mean retention time was 3.016minutes. The method was linear from 2-10μg/ml 25-DR with a correlation coefficient of 0.9978. Standard deviation, relative standard deviation and coefficient variation of 2, 6, 10μg/ml 25-DR were 0-0.0829, 03.1752, 0-0.0317%, respectively. The recovery of 5, 7, 9μg/ml25-DR was 80.8661, 91.3480 and 111.1457%, respectively. Limits of detection (LoD) and quantification (LoQ) were 0.51 and 1.7μg/ml, respectively. The method has fulfilled the validity guidelines of the International Conference on Harmonization (ICH) bioanalytical method which includes parameters of specificity, linearity, precision, accuracy, LoD, and LoQ. The developed method is suitable for pharmacokinetic analysis of various concentrations of 25-DR in human urine.