RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF NEBIVOLOL AND VALSARTAN IN BULK AND DOSAGE FORMAbstract
The several spectrophotometric and HPLC methods have been reported for determination of Nebivolol and Valsartan individually or in combination with other drugs in pharmaceutical dosage forms. Hence, in the present study, a new, sensitive, suitable and cost-effective Reversed-Phase High-Performance Liquid Chromatography method was developed and validated for the determination of Nebivolol and Valsartan in bulk and tablet formulation. In RP-HPLC method, the analyte was resolved by using a gradient system, methanol and water OPA 0.1% (70:30 v/v) pH 3.5 was used as mobile phase, at a flow rate of 0.7 ml/min, on HPLC system containing UV- detector with Workstation Software and Greece C18 column (4.6 × 250 mm; 5μm). The detection was carried out at 274 nm. The retention time was found to be 5.0500 min and 9.7167 min for Nebivolol hydrochloride and Valsartan respectively. The method gave the good resolution and suitable retention time. The results of the analysis in the method were validated regarding accuracy, precision, specificity, linearity, limit of detection, limit of quantification and robustness. A simple and precise method was developed for the assay of Nebivolol and Valsartan from tablet formulation. The method does not require the use of expensive reagent and also less time consuming, it can be performed routinely in the industry for routine analysis of the marketed product of Nebivolol and Valsartan.
P. B. Jadhav * and C. D. Parwe
Department of Pharmaceutical Chemistry, S. N. D. College of Pharmacy, Yeola, Nashik, Maharashtra, India.
24 May 2018
01 August 2018
07 August 2018
01 February, 2019