Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC FOR THE SIMULTANEOUS ESTIMATION OF NEBIVOLOL AND VALSARTAN IN BULK AND COMBINED TABLET DOSAGE FORM

Bhavana D. Dabhade*, Dr. Vijay P. Sonar, Dr. Shashikant D. Bharate and Sunil Bavaskr

Abstract

Nebivolol is a beta blocker with a unique function which distinguishes it from other beta blockers. It increases the release of nitric oxide (NO) which produces vasodilatation and thereby improves arterial compliance and reduces peripheral vascular resistance. It also reduces heart rate without improving maximal exercise tolerance. These effects are beneficial in hypertension and angina pectoris. A simple development and validation of RP-HPLC for the simultaneous estimation of Nebivolol and Valsartan in bulk and combined tablet Dosage form. For the RP - HPLC method Younglin (S.K) Gradient System UV Detector and Grace C18 column with 150mm x4.6 mm i.d and 5μm particle size Methanol: Acetonitrile:H2O (OPA 0.05% ),(15+45+40% v/v) pH 3.0 was used as the mobile phase for the method. The detection wavelength was 273nm and flow rate was 1ml/min. In the developed method, the retention time of Nebivolol and Valsartan were found to be be 3.7667 and 5.4667 min. The developed method was validated according to the ICH guidelines. The linearity, precision, range, robustness were within the limits as specified by the ICH guidelines. Hence the method was found to be simple, accurate, precise, economic and reproducible. So the proposed methods can be used for the routine quality control analysis Nebivolol and Valsartan in bulk drug as well as in formulations.

Keywords: Nebivolol and Valsartan, Method validation, RP- HPLC, ICH, C18.