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

[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.

[学科分类] 分析化学

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