Simultaneous Quantification and Validation of Emtricitabine and Tenofovir Disoproxil Fumarate in a Tablet Dosage Form

Eurasian Journal of Analytical Chemistry

Rajesh Sharma¹  Pooja Gupta¹ 

关键词: Ivabradine HCL;    Pharmaceutical Dosage Form;    RP-HPLC. Spectrophotometric;    UV detector;   

DOI  :  10.12973/ejac.2009.00072a

学科分类：分析化学

来源: Eurasian Journal of Analytical Chemistry

【 摘 要 】

A simple, rapid reversed-phase high performance liquid chromatographic method had been developed and validated for estimation of emtricitabine and tenofovir disoproxil fumarate in tablet dosage form. The estimation was carried out on Luna C18 (25cm x 4.60 mm, particle size 5µm) column with a mixture of acetonitrile: potassium dihydrogen phosphate buffer (pH 3.0 ± 0.05 adjusted with orthophosphoric acid): triethylamine in the ratio of 70:30:0.5(v/v) as mobile phase. UV detection was performed at 260 nm. The method was validated for linearity, accuracy, precision, specificity and sensitivity as per ICH norms. The developed and validated method was successfully used for the quantitative analysis of commercially available dosage form. The retention time was 1.78 and 2.27 min. for emtricitabine and tenofovir disoproxil fumarate respectively and total run time was 4 min. at a flow rate of 1.5 mLmin^-1. The calibration curve was linear over the concentration range of 5-50 µgmL^-1 for emtricitabine and 5-50 µgmL^-1 for tenofovir disoproxil fumarate. The LOD values were 0.015 and 0.039 µgmL^-1 and LOQ are 0.045 and 0.117 µgmL^-1 for emtricitabine and tenofovir disoproxil fumarate respectively. The high percentage of recovery and low percentage coefficient of variance confirm the suitability of the method for the simultaneous estimation of emtricitabine and tenofovir disoproxil fumarate in tablet dosage form.

【 授权许可】

Unknown