ABSTRACT:
A simple, rapid, sensitive, linear, precise, accurate, rugged and robust RP-HPLC-PDA method was developed and validated for the determination of emtricitabine in bulk and capsule dosage form. Reversed-phase chromatography was performed on BDS hypersil C-18 (250 mm × 4.6 mm, 5 micrometer) column of Waters HPLC with Empower software. Methanol: water: acetonitrile 80:13.5:6.5 (v/v/v) was used as mobile phase at a flow rate of 1 mL min-1 with PDA detection at 239 nm. The retention time of emtricitabine was 2.78 min. Linearity was observed in the concentration range of 2-200 microgram mL-1 with regression equation y = 53699x + 122068 (R2 = 0.9998). The method was validated as per ICH guidelines. The %RSD for intra-day and inter-day precision were found to be less than 1 %. The percentage assay of emtricitabine was 100.44% and the percentage recovery was in good agreement with the labelled amount in the pharmaceutical formulation. The proposed method is simple, rapid, sensitive, linear, precise, accurate, robust and rugged and hence applied for the determination of emtricitabine in bulk and pharmaceutical dosage form.