Simple validated isocratic RP - LC method for estimation of Ritonavir in bulk and tablet dosage form

[摘要] A simple, rapid reversed-phase high performance liquid chromatographic method had been developed and validated for estimation of Ritonavir in tablet dosage form. The estimation was carried out on HiQSil C18 (25cm x 4.60 mm, particle size 5μm) column with a mixture of methanol: acetonitrile: water in the ratio of 87:10:3(v/v/v) as mobile phase. UV detection was performed at 240 nm. The method was validated for linearity, accuracy, precision, specificity and sensitivity as per ICH norms. The developed and validated method was successfully used for the quantitative analysis of commercially available dosage form. The retention time was 3.6 min. for Ritonavir and total run time was 10 min. at a flow rate of 1.0 ml/min. The calibration curve was linear over the concentration range of 25 - 200 μg/ml for Ritonavir. The LOD and LOQ values were found to be 0.286μg/ml and 0.858μg/ml. The high percentage of recovery and low percentage coefficient of variance confirm the suitability of the method for the estimation of Ritonavir in tablet dosage form.

[学科分类] 药理学