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Simultaneous Estimation and Validation of Amlodipine Besylate and Nebivolol Hydrochloride in Tablet Formulation by RP-HPLC Method


Affiliations
1 Department of Pharmaceutical Analysis, Nandha College of Pharmacy, Erode-638052, Tamil Nadu, India
2 Department of Pharmaceutical Chemistry, Balaji Institute of Pharmaceutical Sciences, Narsampet, Warangal-506331, Andhra Pradesh, India
     

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A simple, selective and rapid reversed phase high performance liquid chromatographic (RP-HPLC) method has been developed for the simultaneous estimation of Amlodipine Besylate and Nebivolol Hydrochloride from their tablet formulation. The method is carried out on a nucleosil C18 (25 cm×4.6 mm) column with the mobile phase consisting of 0.01 M tetra butyl ammonium hydrogen sulphate: acetonitrile (60:40 v/v) and adjusted the pH to 3.0 by using trimethyl amine, at the flow rate of 1.0 ml min-1. Detection is performed at 264 nm. The retention time of Amlodipine Besylate and Nebivolol Hydrochloride was 2.55 and 5.44 min respectively. The developed method was validated for linearity, accuracy, precision, solution stability, robustness, limit of detection, and limit of quantification. The proposed method can be used for routine analysis of drugs in combined dosage forms.

Keywords

Amlodipine Besylate, Nebivolol Hydrochloride, RP-HPLC, Tablets.
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  • Simultaneous Estimation and Validation of Amlodipine Besylate and Nebivolol Hydrochloride in Tablet Formulation by RP-HPLC Method

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Authors

M. Jagadeeswaran
Department of Pharmaceutical Analysis, Nandha College of Pharmacy, Erode-638052, Tamil Nadu, India
N. Gopal
Department of Pharmaceutical Chemistry, Balaji Institute of Pharmaceutical Sciences, Narsampet, Warangal-506331, Andhra Pradesh, India
T. Sivakumar
Department of Pharmaceutical Analysis, Nandha College of Pharmacy, Erode-638052, Tamil Nadu, India

Abstract


A simple, selective and rapid reversed phase high performance liquid chromatographic (RP-HPLC) method has been developed for the simultaneous estimation of Amlodipine Besylate and Nebivolol Hydrochloride from their tablet formulation. The method is carried out on a nucleosil C18 (25 cm×4.6 mm) column with the mobile phase consisting of 0.01 M tetra butyl ammonium hydrogen sulphate: acetonitrile (60:40 v/v) and adjusted the pH to 3.0 by using trimethyl amine, at the flow rate of 1.0 ml min-1. Detection is performed at 264 nm. The retention time of Amlodipine Besylate and Nebivolol Hydrochloride was 2.55 and 5.44 min respectively. The developed method was validated for linearity, accuracy, precision, solution stability, robustness, limit of detection, and limit of quantification. The proposed method can be used for routine analysis of drugs in combined dosage forms.

Keywords


Amlodipine Besylate, Nebivolol Hydrochloride, RP-HPLC, Tablets.