A validated RP-HPLC method for simultaneous estimation of nebivolol and hydrochlorothiazide in tablets

Sn Meyyanathan,S Rajan,S Muralidharan,B Suresh,Arunadevis Birajdar

doi:10.4103/0250-474x.45420

Abstract

A simple, selective, rapid, precise and economical reverse phase high pressure liquid chromatographic method has been developed for the simultaneous estimation of nebivolol and hydrochlorthiazide from pharmaceutical formulation. Phenomenex Gemini C18 (25 cm×4.6 mm i.d., 5 μ) column with a mobile phase consisting of acetonitrile: 50mM ammonium acetate (adjusted to pH 3.5 using orthophosphoric acid) (70:30 v/v) at a flow rate of 1.0 ml/min was used. Detection was carried out at 254 nm. Probenecid was used as an internal standard. The retention times of probenecid, nebivolol and hydrochlorthiazide were 13.05, 3.32 and 4.25 min, respectively. The developed method was validated in terms of accuracy, precision, linearity, limit of detection, limit of quantitation and solution stability. The proposed method can be used for the estimation of these drugs in combined dosage forms.

Highlights

A simple, selective, rapid, precise and economical reverse phase high pressure liquid chromatographic method has been developed for the simultaneous estimation of nebivolol and hydrochlorthiazide from pharmaceutical formulation
The present work describes the development of a validated RP-HPLC method, which can quantify these components simultaneously from a combined dosage form and the method, was validated following the ICH guidelines[16]
Reference standards of nebivolol and hydrochlorothiazide were obtained from Unichem Pharmaceuticals, Mumbai and probenecid was procured from Cadila Pharmaceuticals Ltd, Ahmedabad

Summary

Introduction

A simple, selective, rapid, precise and economical reverse phase high pressure liquid chromatographic method has been developed for the simultaneous estimation of nebivolol and hydrochlorthiazide from pharmaceutical formulation. Many methods have been described in the literature for the determination of nebivolol and hydrochlorothiazide individually and in combination with other drugs2-15. Reference standards of nebivolol and hydrochlorothiazide were obtained from Unichem Pharmaceuticals, Mumbai and probenecid was procured from Cadila Pharmaceuticals Ltd, Ahmedabad.

Results

Conclusion