Journal américain de l'administration avancée de médicaments Libre accès

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Method Development and Validation of Stability Indicating RP-HPLC Method for Simultaneous Estimation of Nebivolol HCL and Valsartan in Bulk and its Pharmaceutical Formulations

Kalpana Nekkala, V. Shanmukha Kumar J, D. Ramachandran, Ganji Ramanaiah and Ganta Srinivas

A simple, robust, precise HPLC method was developed and the method has been validated for the estimation of valsartan and nebivolol simultaneously in its combined dosage forms as well as individual formulations. Both the compounds are well resolved in a isocratic method by using the mobile phase composition of acetonitrile: methanol: pH4.0 0.02M Potassium hydrogen phosphate buffer in the ratio of 50:20:30 v/v at a flow rate of 1.0mL/min using a C-18 column. The detection was carried out at 210nm.. The retention time of Nebivolol and Valsartan were 2.5 min and 4.3 min respectively. The developed method was validated for specificity, linearity, precision, accuracy, limit of detection (LOD), limit of quantification (LOQ) and robustness as per ICH guidelines. Linearity for Nebivolol and Valsartan were found in the range of 48-112 µg/ml and 3.0-7.0 µg/ml, respectively. The percentage recoveries for Nebivolol and Valsartan ranged from 98.9-100.8 % and 98.9-101.1 %, respectively. The proposed method could be used for routine analysis of Nebivolol and Valsartan in their combined dosage forms.

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