Present study describes the development and subsequent validation of reverse phase high performance liquid chromatographic (RP-HPLC) method for estimation of Darunavir (Figure 1) a retroviral drug in bulk and its formulation with greater precision and accuracy. Separation was achieved on C18 column (250 x 4.6 mm id.5 µm) in isocratic mode using water: methanol (0.2 % TEA) in the ratio of 30 : 70 (v / v) pH adjusted to 3 as mobile phase, pumped into column at flow rate 1.0 ml / min and the detection of eluent was carried out at 262 nm. Retention time was obtained at 5.2 minutes; total run time was set to 8 minutes. The standard curves were linear over the concentration range of 5-50 µg / ml with correlation coefficient 0.9995 and the LOD and LOQ values were 0.48 µg / ml and 1.5 µg / ml respectively. The percentage recovery was found to be within 98.2 % -101.2 %. The % RSD of intra-day and inter-day precision was found to be 0.69 and 1.3 for the assay concentration respectively. The percentage amount of marketed tablet formulation of Darunavir was found to be 99.66 %. The robustness of method has been studied by slightly varying the chromatographic conditions. Validation studies demonstrated that proposed RP-HPLC method is simple, specific, rapid, reliable and reproducible.
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