Nebivolol HCl and Indapamide tablet is newly approved combination by CDSCO for the treatment of treatment of hypertension in patients whose blood pressure is not adequately controlled by monotherapy on 12 May 2010. Stability indicating HPLC method was developed using C18 (250 mm x 4.6 mm i.d., 5 μm particle size) column with Buffer : ACN (Acetonitrile) (25:75, pH 3.5 0.02 m KH2PO4 with Tryethylamine) as mobile phase with flow rate was 1.0 ml/min and detection wavelength 310 nm. In RP-HPLC method linearity ranged from 25-75 μg/mL for Nebivolol HCl and 7.5-22.5 μg/mL for Indapamide. Correlation coefficient was greater than 0.999 and accuracy (%Recovery) was between 98% - 102% for both drugs. The method successfully separated both the drugs from degradation products formed under acid hydrolysis, alkali hydrolysis, oxidative, photolytic and thermal stress conditions establishing specifity of the method. Moreover, the % RSD for repeatability, inter and intraday precision was found to be less than 2%, which reveals that the method is precise. In stress study both the drugs were found to degrade significantly under hypo alkaline acidic, oxidative and thermal conditions whereas the degradation was marginal under the sunlight exposure conditions. The proposed RP-HPLC stability indicating method can be successfully employed in estimation of tablet dosage form in regular QC and stability analysis.
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