Development and Validation of RP-HPLC Method for the Estimation of Rifapentine in Bulk and Pharmaceutical Formulation
American Journal of Advanced Drug Delivery(2014)
摘要
A simple, accurate, precise and sensitive reverse phase high performance liquid chromatography method was developed for estimation of Rifapentine in bulk and pharmaceutical dosage form. For HPLC method, Column: C18 (4.6ID x 250mm) in isocratic mode with mobile phase containing Acetonitrile: 0.01M KH 2 PO 4 buffer pH (6.0) in ratio of 80: 20 v/v was used. The flow rate was 0.8 ml/min with injection volume of 20µl and effluent was monitored at 478nm. Retention time was found to be 5.00 ± 0.1 minute. The method was validated for several parameters like accuracy, linearity, precision etc, as per ICH guidelines. The values of relative standard deviation and % recovery were found to be satisfactory, indicating that the proposed method is precise and accurate and hence can be used for the routine analysis of Rifapentine in bulk and pharmaceutical formulation.
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