Development and validation of RP-HPLC method for ritonavir in bulk and pharamceutical dosage forms
Keywords:Ritonavir, Anti HIV drugs, Validation, RP-HPLC, ICH guidelines.
A reverse phase high-performance liquid chromatographic method was developed and validated for the quantitative determination of Ritonavir. Chromatographic method was carried out by isocratic technique using C18 Column, Phenomenex (250 x 4.6 mm, 5 μ), with mobile phase mixture of acetonitrile: methanol 70:30(V/V) and at a flow rate of 1 mL/min. The retention time obtained for Ritonavir at 3.52 min at 239 nm wavelength. The different analytical parameters such as linearity, precision, accuracy, specificity and robustness, limit of detection (LOD) and limit of quantification (LOQ) were determined according to International Conference on Harmonization guidelines. The linearity of the calibration curves for Ritonavir in the desiredconcentration range is good (r2>0.9). The recovery of the method was between 98% and 102% for Ritonavir. Hence the proposed method is highly sensitive, precise and accurate and it successfully applied for the estimation of API content in the commercial formulations of ritonavir.