A RAPID RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTITATIVE ESTIMATION RIBAVIRIN IN TABLETS
Objective: To develop an accurate, precise and linear Reverse Phase High Performance Liquid Chromatography (RP-HPLC) method and validate as per ICH guidelines for the quantitative estimation of Ribavirin (200mg) in tablets.
Methods: The optimized method uses a reverse phase column, Enable Make KromasilC18 (250 X 4.6 mm; 5Î¼), a mobile phase of phosphate buffer (pH 4.2): acetonitrile in the proportion of 85:15 v/v, flow rate of 1.0 ml/min and a detection wavelength of 215 nm using a PDA detector.
Results: The developed method resulted in Ribavirin eluting at 2.606 min. Ribavirin exhibited linear in the range 25-150Î¼g/ml. The precision is exemplified by the relative standard deviation of 0.4%. Percentage Mean recovery was found to be in the range of 98â€102, during accuracy studies. The limit of detection (LOD) and limit of quantitiation (LOQ) was found to be 0.24ng/ml and 0.73ng/ml respectively.
Conclusion: An accurate, precise and linear RP-HPLC method was developed and validated for the quantitative estimation of Ribavirin in VIRAZIDE (200mg) tablets as per ICH guidelines and hence it can be used for the routine analysis in various pharmaceutical industries.
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