HPLC Method Development and Validation for Estimation of Ivabradine and Carvedilol Bulk and Dosage Form by using QBD Approach

Attempts were made to develop an RP-HPLC method for the simultaneous estimation of Carvedilol & Ivabradine from Tablet. For the RP Agilent Tech. Gradient System with Auto injector, UV (DAD) & Gradient Detector Reverse Phase (Waters) C18 column (4.6mm x 100mm; 2µm), a 20µl injection loop and UV730D Absorbance detector and running chemstation 10.1 software. RP-HPLC method was developed by implementing QbD methodology on analytical column- Reversed Phase Agilent C18 (250mm×4.6mm×5µm), with mobile phase Methanol: (0.1% OPA) Water (42.4:57.6 v/v). The flow rate used was 0.6 mL /min, and UV detection was carried out at 275 nm. The retention time for Carvedilol & Ivabradine was found to be 5.282 min & 6.808 min respectively.Systematic approach was utilized to develop an efficient and robust method which includes beginning with the determination of target profile characteristics, risk assessment, design of experiment and validation. The study was done by using 22 full fraction response surface designs. In this study interaction of 2 factors; flow rate, mobile phase composition at 2 levels.Method Operable Design Region (MODR) was developed to achieve the region of operation for drug and Ivabradine.The proposed HPLC method has also been evaluated for accuracy, precision and robustness and proved to be convenient and effective for the quality control of Carvedilol & amp; Ivabradine.