HPLC Analysis of Lamivudine in Pharmaceutical Formulations: Method Development and Validation

We developed a novel, rapid and efficient high performance liquid chromatography (HPLC) method and validated to analyse the quantification of Lamivudine (LAM) in different pharmaceutical formulations, including pure form, commercial tablet, and nanostructured lipid carrier (NLC), a novel drug carrier system. Accurate analysis of the amount of active ingredient in pharmaceutical formulations is very important for assessment of the quality and therapeutic efficacy of formulations. In method, we used distilled water: methanol (MeOH) (60:40 v/v) as mobile phase and analysed on C18 column. To analyse the eluent, the method was performed at 270 nm, with a flow rate of 1 mL/min, in 10 min. The calibration curve obtained showed linearity in the concentration range 2-60 ppm. The average recovery of pharmaceutical preparations (Zeffix, GlaxoSmithKline tablets and NLC formulation) was 99.552%. Our method’s limit of detection (LOD) was 1.494 μg/mL. Our method’s limit of quantification (LOQ) was 0.514 μg/mL. The method also allowed the determination of the amount of LAM contained in the existing commercial formulation and the newly developed NLC formulation and the verification of the homogeneity of the pharmaceutical formulations. The results obtained show that the developed HPLC method can be used reliably in both formulation development and stability studies in NLC drug carrier systems.