Abstract :
This study created and validated a straightforward, precise, and reliable reverse-phase high-performance liquid chromatographic (RP-HPLC) method for the simultaneous quantification of the HIV-1 medications lamivudine (LAV) and raltegravir (RAV) in bulk and tablet forms in order to address the need for quality control of the combined drugs in fixed-dose formulations. Using a mobile phase of phosphate buffer (pH 3.0) and acetonitrile (55:45, v/v) at 1.0 mL/min, chromatographic separation was accomplished on an Inertsil ODS 3V column and detected at 275 nm. Within 10 minutes, the approach produced distinct, well-defined peaks. The technique showed outstanding linearity over the defined concentration ranges (LAV: 50 150 ?g/mL, r 2 = 0.9986; RAV: 150–450 ?g/mL, r 2 = 0.9998). High precision and accuracy were validated by recovery values close to 100% and %RSD less than 2.0%. The tablets had assay findings of 102.50% (RAV) and 99.54% (LAV). Additionally, the approach was robust and sensitive.For routine quality control and stability analysis of RAV and LAV in combination pharmaceutical dosage forms, this RP-HPLC method is appropriate, having been validated in accordance with ICH Q2(R1) recommendations.
Keyword :
Raltegravir, Lamivudine, RP-HPLC, method validation, ICH Q2(R1)