METHOD DEVELOPMENT AND VALIDATION FOR NEBIVOLOL AND VALSARTAN BY RP- HPLC METHOD
Chittedi Anand Reddy, Dr. Khaja Zeeyauddin and Yagnambhatla Rajendra*
ABSTRACT
Objective: A simple, Accurate, precise method was developed for the simultaneous estimation of the Nebivolol and Valsartan in pharmaceutical dosage form. Methods: Chromatogram was run through Cosmosil C18 column (250 × 4.6 mm, 5 μm). Mobile phase containing methanol: water (0.1% OPA in 100 ml) pH 3.5 (70:30) was pumped through column at a flow rate of 1ml/min. Buffer used at pH 3.5. Temperature was maintained at Ambient. Optimized wavelength for Nebivolol and Valsartan was 272 nm. Results: Retention time of Nebivolol and Valsartan were found to be 5.04 min and 9.71 min. The % purity of Nebivolol and Valsartan was found to be 100.03 % and 99.75 % respectively. The system suitability parameters for Nebivolol and Valsartan such as theoretical plates and tailing factor were found to be 3535, 1.51 and 6511, 1.17. the resolution was found to be 8.0. The linearity study for Nebivolol and Valsartan was found in concentration range of 5μg-25 μg and 80 μg-400 μg and correlation coefficient (r2) was found to be 0.999 and 0.999, % mean recovery was found to be 100.37 % and 99.57 %, %RSD for repeatability was 1.98 and 0.54 %. The precision study was precise, robust and repeatable. LOD value was 0.262 and 0.6, and LOQ value was 0.68 and 2.11 respectively. Conclusion: The results of study showed that the proposed RP‐HPLC method is a simple, accurate, precise, rugged, robust, fast and reproducible, which may be useful for the routine estimation of Nebivolol and Valsartan in pharmaceutical dosage form.
Keywords: Nebivolol, Valsartan, RP?HPLC, Simultaneous estimation.
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