Abstract
A simple, accurate, precise and sensitive reverse phase high performance liquid chromatography (RP-HPLC) method has been developed, which can separate and quantitatively estimate Lamivudine and Tenofovir disoproxil fumarate in mixed dosage form. The chromatographic separation for Lamivudine and Tenofovir disoproxil fumarate was achieved with mobile phase containing acetonitrile and phosphate buffer PH 3.5 (80:20 % v/v), reverse phase Thermo scientificTMHypersilTMBDS 5µ C18 120A (250 × 4.60 mm i.d ) column in isocratic mode at room temperature and UV detection at 260nm. The compounds were eluted at a flow rate of 1.2 ml/min. The retention times of Lamivudine and Tenofovir disoproxil fumarate were found to be 2.33min and 2.68min respectively. The above method was validated in terms of system suitability, linearity, accuracy, precision, Limit of Detection (LOD), Limit of Quantification (LOQ) in accordance with ICH guidelines. The method was rapid, simple, economical and suitable for routine quality control analysis.
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