Abstract

IMPLEMENTATION OF QUALITY BY DESIGN APPROACH TO ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF ANTI-HYPERTENSIVE DRUGS BY RP-HPLC METHOD

Seba Ghosh*, Sourav Ghosh, Anirbandeep Bose and Divakar Goli

ABSTRACT

A RP-HPLC method was developed for Valsartan and Nebivolol Hydrochloride in bulk and pharmaceutical dosage form using Phenomenex kinetics C18 column (250 mm × 4.6 mm, 5 μ) and optimized using Quality by Design approach with a mobile phase of Acetonitrile: Water (70: 30 v/v), at flow rate 1.0 ml/min with UV detection at 280 nm. The retention time of Valsartan and Nebivolol Hydrochloride were found to be 1.7 minute and 6.6 minute respectively. The proposed method was validated for system suitability, specificity, linearity, accuracy, precision, LOD, LOQ, and robustness. All parameters were found to be within the acceptance limit. Linearity for Valsartan and Nebivolol HCl were in the range of 16-80 μg/ml and 1-5 μg/ml. The regression co-efficient (r2) were found to be 0.995 and 0.999 for Valsartan and Nebivolol Hydrochloride. The percentage recovery for Valsartan and Nebivolol Hydrochloride were found to be 101.6%-101.25% and 98.5-98.49% respectively. LOD values were found to be 1.6 μg/ml and 2.20 μg/ml and LOQ values were found to be 5 μg/ml and 6.67 μg/ml for Valsartan and Nebivolol Hydrochloride respectively. Design expert software trial version 11 (stat-ease) was used to optimize the method. RSM was employed to design the experiment where the predicted values were verified and it satisfied the actual experimental data.

Keywords: RP-HPLC Method, QbD, RSM, Valsartan and Nebivolol HCl.