New Validated Rp-HPLC Method for the Estimation of Darunavir in Bulk and Its Dosage Form

Abstract

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.

Analytical Method Development for the Estimation of Darunavir by Diazotization and Coupling by Visible Spectrophotometry

“…Few reversed-phase high-performance liquid chromatography methods [1][2][3][4][5][6], UV/visible methods [7][8][9][10], and high-performance thinlayer chromatography (HPTLC) methods [11] were found through the extensive literature search on the quantization of DNV in pure and dosage forms. The existing HPLC and HPTLC methods are laborious, timeconsuming and need sample pretreatment.…”